Trial Outcomes & Findings for Lithium As a Treatment to Prevent Impairment of Cognition in Elders (NCT NCT03185208)
NCT ID: NCT03185208
Last Updated: 2025-09-11
Results Overview
California Verbal Learning Test II. Long-delay free recall. Scores range from 0 - 16; higher means better.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
Year 1 and Year 2
Results posted on
2025-09-11
Participant Flow
Following Data and Safety Monitoring Board approval 9/1/2017, the first participant enrolled 2/2/2018, and last enrolled 8/29/2022. Recruitment involved senior centers, education classes, communities, housing, internet methods, University of Pittsburgh Alzheimer's Disease Research Center partnerships, primary care practices, former participants. During the pandemic, internet/print ads replaced in-person activities.
Participant milestones
| Measure |
Lithium Carbonate
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels to a steady blood level between 0.6 and 0.8 meq/L or the maximum tolerated dose based on side effects if lower. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Lithium Carbonate
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels to a steady blood level between 0.6 and 0.8 meq/L or the maximum tolerated dose based on side effects if lower. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Overall Study
Did not start study medication
|
0
|
3
|
Baseline Characteristics
Pooled mean and pooled standard deviation.
Baseline characteristics by cohort
| Measure |
Lithium Carbonate
n=41 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.93 years
STANDARD_DEVIATION 8.77 • n=41 Participants • Pooled mean and pooled standard deviation.
|
71.22 years
STANDARD_DEVIATION 6.47 • n=39 Participants • Pooled mean and pooled standard deviation.
|
72.10 years
STANDARD_DEVIATION 7.73 • n=80 Participants • Pooled mean and pooled standard deviation.
|
|
Sex: Female, Male
Female
|
23 Participants
n=41 Participants
|
22 Participants
n=39 Participants
|
45 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=41 Participants
|
17 Participants
n=39 Participants
|
35 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=41 Participants
|
38 Participants
n=39 Participants
|
79 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=41 Participants
|
5 Participants
n=39 Participants
|
8 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=41 Participants
|
33 Participants
n=39 Participants
|
71 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Education (years)
|
15.46 years
STANDARD_DEVIATION 2.66 • n=41 Participants
|
16.54 years
STANDARD_DEVIATION 1.8 • n=39 Participants
|
15.99 years
STANDARD_DEVIATION 2.33 • n=80 Participants
|
|
Amyloid-beta
Amyloid-beta negative
|
27 Participants
n=41 Participants
|
27 Participants
n=39 Participants
|
54 Participants
n=80 Participants
|
|
Amyloid-beta
Amyloid-beta positive
|
11 Participants
n=41 Participants
|
10 Participants
n=39 Participants
|
21 Participants
n=80 Participants
|
|
Amyloid-beta
Amyloid-beta unknown
|
3 Participants
n=41 Participants
|
2 Participants
n=39 Participants
|
5 Participants
n=80 Participants
|
|
Mild Cognitive Impairment
Amnestic
|
34 Participants
n=41 Participants
|
28 Participants
n=39 Participants
|
62 Participants
n=80 Participants
|
|
Mild Cognitive Impairment
Not Amnestic
|
7 Participants
n=41 Participants
|
11 Participants
n=39 Participants
|
18 Participants
n=80 Participants
|
|
APOE e4 allele
Non-carrier
|
26 Participants
n=41 Participants
|
26 Participants
n=39 Participants
|
52 Participants
n=80 Participants
|
|
APOE e4 allele
Carrier
|
15 Participants
n=41 Participants
|
13 Participants
n=39 Participants
|
28 Participants
n=80 Participants
|
|
Framingham Stroke Risk Profile
|
13 percentage
STANDARD_DEVIATION 12 • n=41 Participants
|
11 percentage
STANDARD_DEVIATION 12 • n=39 Participants
|
12 percentage
STANDARD_DEVIATION 12 • n=80 Participants
|
|
Cumulative Illness Rating Scale-Geriatric
|
11.07 units on a scale
STANDARD_DEVIATION 4.67 • n=41 Participants
|
9.9 units on a scale
STANDARD_DEVIATION 3.61 • n=39 Participants
|
10.50 units on a scale
STANDARD_DEVIATION 4.2 • n=80 Participants
|
|
Creatinine
|
0.84 mg/dL
STANDARD_DEVIATION 0.16 • n=41 Participants
|
0.92 mg/dL
STANDARD_DEVIATION 0.14 • n=39 Participants
|
0.88 mg/dL
STANDARD_DEVIATION 0.15 • n=80 Participants
|
|
Glomerular Filtration Rate (GFR)
|
84.23 mL/min/1.73m^2
STANDARD_DEVIATION 11.74 • n=41 Participants
|
77.95 mL/min/1.73m^2
STANDARD_DEVIATION 13.11 • n=39 Participants
|
81.17 mL/min/1.73m^2
STANDARD_DEVIATION 12.74 • n=80 Participants
|
|
Medication count
|
7.78 Number of medications
STANDARD_DEVIATION 5.22 • n=41 Participants
|
6.64 Number of medications
STANDARD_DEVIATION 4.84 • n=39 Participants
|
7.23 Number of medications
STANDARD_DEVIATION 5.04 • n=80 Participants
|
|
Anticholinergic Burden
|
2.53 units on a scale
STANDARD_DEVIATION 2.39 • n=41 Participants
|
2.34 units on a scale
STANDARD_DEVIATION 2.85 • n=39 Participants
|
2.44 units on a scale
STANDARD_DEVIATION 2.61 • n=80 Participants
|
|
Physical Activity Scale for the Elderly (PASE)
|
117.01 units on a scale
STANDARD_DEVIATION 73.65 • n=41 Participants
|
90.20 units on a scale
STANDARD_DEVIATION 50.91 • n=39 Participants
|
103.77 units on a scale
STANDARD_DEVIATION 64.47 • n=80 Participants
|
|
Patient Health Questionnaire-9 item (PHQ-9)
|
3.88 units on a scale
STANDARD_DEVIATION 3.27 • n=41 Participants
|
3.49 units on a scale
STANDARD_DEVIATION 3.46 • n=39 Participants
|
3.69 units on a scale
STANDARD_DEVIATION 3.35 • n=80 Participants
|
|
Brief Visual Memory Test Revised (BVMT-R)
|
6.23 units on a scale
STANDARD_DEVIATION 3.11 • n=40 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
6.56 units on a scale
STANDARD_DEVIATION 2.86 • n=39 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
6.39 units on a scale
STANDARD_DEVIATION 2.98 • n=79 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
|
California Verbal Learning Test 2nd edition (CVLT-II)
|
7.95 units on a scale
STANDARD_DEVIATION 3.4 • n=40 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
7.90 units on a scale
STANDARD_DEVIATION 3.9 • n=39 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
7.92 units on a scale
STANDARD_DEVIATION 3.63 • n=79 Participants • One participant in Group lithium did not receive the BVMT-R and CVLT-II because she had substantial familiarity with those tests.
|
|
Preclinical Alzheimer's Cognitive Composite (PACC)
|
-0.36 Z-score
STANDARD_DEVIATION 3.59 • n=41 Participants • Three Group placebo participants had missing data, preventing calculation of their PACC scores.
|
0.41 Z-score
STANDARD_DEVIATION 3.16 • n=36 Participants • Three Group placebo participants had missing data, preventing calculation of their PACC scores.
|
0.00 Z-score
STANDARD_DEVIATION 3.39 • n=77 Participants • Three Group placebo participants had missing data, preventing calculation of their PACC scores.
|
|
Hippocampal volume
|
7387 mm^3
STANDARD_DEVIATION 1293 • n=33 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
7199 mm^3
STANDARD_DEVIATION 801 • n=29 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
7299 mm^3
STANDARD_DEVIATION 1087 • n=62 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
|
Cerebral Cortical Gray Matter
|
416997 mm^3
STANDARD_DEVIATION 51634 • n=33 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
410702 mm^3
STANDARD_DEVIATION 40439 • n=29 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
414053 mm^3
STANDARD_DEVIATION 46468 • n=62 Participants • 18 participants were unable to complete neuroimaging or images were not analyzable.
|
|
Brain derived neurotrophic factor
|
14.61 Log transformed number of molecules
STANDARD_DEVIATION 0.83 • n=36 Participants • Seven participants had missing BDNF values at baseline due to insufficient blood samples or for failing quality control.
|
14.41 Log transformed number of molecules
STANDARD_DEVIATION 1.47 • n=37 Participants • Seven participants had missing BDNF values at baseline due to insufficient blood samples or for failing quality control.
|
14.51 Log transformed number of molecules
STANDARD_DEVIATION 1.19 • n=73 Participants • Seven participants had missing BDNF values at baseline due to insufficient blood samples or for failing quality control.
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
California Verbal Learning Test II. Long-delay free recall. Scores range from 0 - 16; higher means better.
Outcome measures
| Measure |
Lithium Carbonate
n=40 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
California Verbal Learning Test II
Year 1
|
6.9 units on a scale
Standard Deviation 4.0
|
6.2 units on a scale
Standard Deviation 4.6
|
|
California Verbal Learning Test II
Year 2
|
6.46 units on a scale
Standard Deviation 3.97
|
5.10 units on a scale
Standard Deviation 4.54
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
Brief Visuospatial Memory Test - Revised. Delayed Recall. Scores range from 0 - 12; higher means better.
Outcome measures
| Measure |
Lithium Carbonate
n=40 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Brief Visuospatial Memory Test - Revised
Year 1
|
5.97 units on a scale
Standard Deviation 3.2
|
5.9 units on a scale
Standard Deviation 3.1
|
|
Brief Visuospatial Memory Test - Revised
Year 2
|
5.69 units on a scale
Standard Deviation 3.4
|
6.19 units on a scale
Standard Deviation 3.73
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
Cognitive testing measures with a composite of memory, executive function, processing speed, activities of daily living, and general cognition tests. Values are Z-scores. Higher values mean better cognition. A Z-score of 0 represents the population mean, while Z-scores of ±1 capture approximately 68% of the data around the mean and Z-scores of ±2 capture approximately 95% of the data in a normal distribution.
Outcome measures
| Measure |
Lithium Carbonate
n=41 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=36 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests
Year 2
|
-0.67 Z-score
Standard Deviation 5.67
|
-0.19 Z-score
Standard Deviation 4.04
|
|
Preclinical Alzheimer Cognitive Composite Composed of Memory and Other Cognitive Tests
Year 1
|
0.10 Z-score
Standard Deviation 4.3
|
0.43 Z-score
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: The researchers could not evaluate GSK-3β as commercial assays failed to reliably measure its activity in plasma.
Values of blood-based biomarkers
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
Brain-Derived Neurotrophic Factor (BDNF) supports neuron survival and growth; reduced levels linked to neurodegeneration. Nucleic Acid-Linked Immuno-Sorbent Assay (NULISA) measures BDNF using nucleic acid-tagged antibody pairs recognizing different BDNF epitopes. Sequential capture/purification via polyA/biotin tails, then ligation and next-generation sequencing quantification achieves attomolar sensitivity alongside hundreds of other proteins.
Outcome measures
| Measure |
Lithium Carbonate
n=41 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Brain-derived Neurotrophic Factor
Year 1
|
14.5 Log transformed number of molecules
Standard Deviation 1.02
|
14.1 Log transformed number of molecules
Standard Deviation 1.71
|
|
Brain-derived Neurotrophic Factor
Year 2
|
14.5 Log transformed number of molecules
Standard Deviation 0.90
|
14.3 Log transformed number of molecules
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
Cerebral cortical gray matter volume as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
Outcome measures
| Measure |
Lithium Carbonate
n=33 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=29 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Cerebral Cortical Gray Matter Volume
Year 1
|
412951 mm^3
Standard Deviation 24063
|
405236 mm^3
Standard Deviation 16950
|
|
Cerebral Cortical Gray Matter Volume
Year 2
|
411270 mm^3
Standard Deviation 27271
|
402212 mm^3
Standard Deviation 19033
|
PRIMARY outcome
Timeframe: Year 1 and Year 2Population: Intention-to-treat analysis; all randomized participants were included regardless of study completion or protocol adherence.
Hippocampal volume values as measured by structural imaging (7T MRI) corrected for age, sex, and intracranial volume
Outcome measures
| Measure |
Lithium Carbonate
n=33 Participants
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=29 Participants
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Hippocampal Volume
Year 1
|
7352 mm^3
Standard Deviation 847
|
7118 mm^3
Standard Deviation 816
|
|
Hippocampal Volume
Year 2
|
7369 mm^3
Standard Deviation 812
|
6884 mm^3
Standard Deviation 922
|
SECONDARY outcome
Timeframe: Year 1 and Year 2Population: CSF collection was not performed due to insufficient participant consent for lumbar puncture procedures.
Cerebrospinal fluid phospho tau levels
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1 and Year 2Exploratory analyses of additional measures of brain integrity, such as lower level of microbleeds, higher white matter integrity, or better network connectivity
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Year 1 and Year 2Population: Valid NIH Toolbox cognitive composite scores were available for only one participant at baseline and 2-year follow-up due to two factors: 1) Coronavirus Disease 2019 (COVID-19) protocol changes required remote administration, for which composite scores are not provided due to unknown validity effects, and 2) composite scores are not available for participants aged 86+. The pandemic timing caused additional missing data, leaving only one participant with complete data across timepoints.
NIH Toolbox performance
Outcome measures
Outcome data not reported
Adverse Events
Lithium Carbonate
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 37 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lithium Carbonate
n=41 participants at risk
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 participants at risk
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Cardiac disorders
Congestive heart failure
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Subdural Hemorrhage
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Vascular disorders
Vasovagal Episode
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Surgical and medical procedures
Total knee replacement
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
Community acquired pneumonia
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung disease
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Nausea and left arm pain
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Dislocation of right hip
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Cardiac disorders
Recurrence of atrial flutter
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Cardiac disorders
Shortness of breath
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
Fever and shortness of breath
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Leg pain and swelling
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Leg wounds
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemia
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Stroke
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Etadolac related ischemic colitis
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
Infectious aortitis
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Bleeding stomach ulcer
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Surgical and medical procedures
Neck surgery
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Fall, fracture of right hip
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Cardiac disorders
Shortness of breath, pedal edema, pulmonary embolism, acute atrial flutter with RVR on chronic CHF
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Frequent falls
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Bilateral hip and leg pain
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Confusion and shortness of breath
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Radiation treatment of malignant skin neoplasm and osteomyelitis
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Total knee athroscopy
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
Other adverse events
| Measure |
Lithium Carbonate
n=41 participants at risk
Lithium carbonate will be initiated at 150 mg per day and increased based on blood levels until a steady blood level between 0.6 and 0.8 meq/L is achieved. Participants will continue at the dose achieved for 2 years with quarterly monitoring.
Lithium Carbonate: See lithium carbonate arm
|
Placebo
n=39 participants at risk
Matching placebo will be initiated and increased based on pretend blood levels. Participants will take placebo for 2 years with quarterly monitoring.
Placebo oral capsule: See placebo arm
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Reduced emotional flattening
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Somniloquy
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Stuttering
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Twitching in sleep
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Weight loss
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Lung inflammation
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Renal and urinary disorders
Increased creatinine
|
29.3%
12/41 • Number of events 16 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
30.8%
12/39 • Number of events 21 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Tremor
|
24.4%
10/41 • Number of events 13 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 18 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Sleepiness
|
24.4%
10/41 • Number of events 19 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
23.1%
9/39 • Number of events 12 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Tiredness
|
29.3%
12/41 • Number of events 19 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 9 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Renal and urinary disorders
Increased urinary frequency
|
9.8%
4/41 • Number of events 9 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 14 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Diarrhea
|
29.3%
12/41 • Number of events 21 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 11 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Dizziness
|
12.2%
5/41 • Number of events 10 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 9 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Dry mouth
|
9.8%
4/41 • Number of events 7 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
7.7%
3/39 • Number of events 6 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Metabolism and nutrition disorders
Weight gain
|
17.1%
7/41 • Number of events 9 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
10.3%
4/39 • Number of events 5 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Endocrine disorders
Increase TSH value
|
17.1%
7/41 • Number of events 7 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
7.7%
3/39 • Number of events 5 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Unsteadiness
|
12.2%
5/41 • Number of events 8 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
7.7%
3/39 • Number of events 7 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Vascular disorders
Edema
|
12.2%
5/41 • Number of events 11 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
4.9%
2/41 • Number of events 4 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
10.3%
4/39 • Number of events 6 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Nausea
|
9.8%
4/41 • Number of events 6 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
5.1%
2/39 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Blood and lymphatic system disorders
Increased calcium value
|
12.2%
5/41 • Number of events 7 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Fatigue
|
9.8%
4/41 • Number of events 4 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
7.7%
3/39 • Number of events 4 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Indigestion
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
5.1%
2/39 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Blood and lymphatic system disorders
Pedal edema
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Concentration difficulties
|
7.3%
3/41 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
5.1%
2/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Memory difficulties
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Metabolism and nutrition disorders
Increased thirst
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Stomach pain
|
2.4%
1/41 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Headache
|
12.2%
5/41 • Number of events 11 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
5.1%
2/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Skin and subcutaneous tissue disorders
Mouth ulcers
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Metallic taste
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Blood and lymphatic system disorders
Electrolyte abnormality
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Hypnogogic hallucination
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Stomach discomfort
|
9.8%
4/41 • Number of events 5 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Falls, recurrent
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Eye disorders
Accommodation Disturbance
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Akathisia
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Eye disorders
Blurred vision
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Cardiac disorders
Congestive heart failure
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
4/41 • Number of events 8 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
7.7%
3/39 • Number of events 4 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Depression
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Disorientation
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Nervous system disorders
Facial nerve palsy
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Facial pain
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Fever
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Heaviness in limbs
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Heel pain
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Hives
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Hot flashes
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Hungriness
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Increased dream activity
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
5.1%
2/39 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Increased sleep duration
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Inner unrest
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Insomnia
|
4.9%
2/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
15.4%
6/39 • Number of events 10 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Psychiatric disorders
Irritability
|
7.3%
3/41 • Number of events 3 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Itchiness
|
2.4%
1/41 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 2 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Leg cramps
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Infections and infestations
Lyme disease
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Injury, poisoning and procedural complications
Mechanical fall
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Renal and urinary disorders
Micturation difficulty
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
0.00%
0/39 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/41 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Night sweats
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
|
General disorders
Palpitations
|
2.4%
1/41 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
2.6%
1/39 • Number of events 1 • At weekly titration visits until participants achieved a steady dose within target range or the maximum tolerated dose, then at monthly/quarterly/annual visits thereafter during their 2 year treatment period. Additional data was collected if participants contacted study staff outside of these visits and reported adverse events, if an extra visit was necessary for added clinical monitoring, or if study staff identified serious adverse events when reviewing medical records.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place