Trial Outcomes & Findings for Contact: Developing New Clinical Management Strategies (NCT NCT03812588)
NCT ID: NCT03812588
Last Updated: 2022-04-21
Results Overview
Scale for depressive symptoms administered by trained rater. The Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. The scoring is based on the first 24 items of the Hamilton. Sum of the scores of the first 24 items (range from 0 to 74): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Up to 8 Weeks
Results posted on
2022-04-21
Participant Flow
In total, 29 subjects were enrolled. Of the 29 enrolled, 4 subjects did not continue in the study after enrolling. These 4 subjects did not appear for their randomization visit at which they would have been assigned to a study arm. Thus, 29 patients enrolled and 25 patients started.
Participant milestones
| Measure |
Clinical Frequency Management: Placebo
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
5
|
8
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contact: Developing New Clinical Management Strategies
Baseline characteristics by cohort
| Measure |
Clinical Frequency Management: Placebo
n=5 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=7 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=5 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
14 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 14.40 • n=39 Participants
|
58 years
STANDARD_DEVIATION 7.26 • n=41 Participants
|
58.8 years
STANDARD_DEVIATION 22.95 • n=35 Participants
|
60 years
STANDARD_DEVIATION 13.77 • n=31 Participants
|
58.32 years
STANDARD_DEVIATION 13.91 • n=146 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
9 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
12 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
25 Participants
n=146 Participants
|
|
Hamilton Rating Scale for Depression
|
18 units on a scale
STANDARD_DEVIATION 4.53 • n=39 Participants
|
20.4 units on a scale
STANDARD_DEVIATION 2.07 • n=41 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 3.65 • n=35 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 4.43 • n=31 Participants
|
19.88 units on a scale
STANDARD_DEVIATION 3.68 • n=146 Participants
|
|
Hamilton Anxiety Rating Scale 14-item Scale
|
10.2 units on a scale
STANDARD_DEVIATION 3.27 • n=39 Participants
|
9.57 units on a scale
STANDARD_DEVIATION 2.15 • n=41 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 4.22 • n=35 Participants
|
9.62 units on a scale
STANDARD_DEVIATION 2.83 • n=31 Participants
|
10.08 units on a scale
STANDARD_DEVIATION 2.96 • n=146 Participants
|
|
Clinical Global Impressions Severity
|
4 units on a scale
STANDARD_DEVIATION 0.71 • n=39 Participants
|
4 units on a scale
STANDARD_DEVIATION 0 • n=41 Participants
|
4 units on a scale
STANDARD_DEVIATION 0 • n=35 Participants
|
4 units on a scale
STANDARD_DEVIATION 0.54 • n=31 Participants
|
4 units on a scale
STANDARD_DEVIATION 0.41 • n=146 Participants
|
PRIMARY outcome
Timeframe: Up to 8 WeeksPopulation: Two CFM, Placebo, two RFM, Placebo, and two CFM, Escitalopram participants did not complete the Hamilton Rating Scale for Depression at Week 8, and so their change from baseline Hamilton Rating scale for Depression score could not be calculated.
Scale for depressive symptoms administered by trained rater. The Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. The scoring is based on the first 24 items of the Hamilton. Sum of the scores of the first 24 items (range from 0 to 74): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression
Outcome measures
| Measure |
Clinical Frequency Management: Placebo
n=3 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=5 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=3 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks)
|
1.33 score on a scale
Standard Deviation 3.51
|
11.4 score on a scale
Standard Deviation 4.04
|
5.33 score on a scale
Standard Deviation 13.65
|
9.25 score on a scale
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: Up to 8 WeeksPopulation: Two CFM, Placebo, two RFM, Placebo, and three CFM, Escitalopram participants did not complete the Hamilton Anxiety at Week 8, and so their change from baseline Hamilton Anxiety score could not be calculated.
Scale for anxiety symptoms administered by trained rater. The Hamilton Anxiety is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Outcome measures
| Measure |
Clinical Frequency Management: Placebo
n=3 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=5 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=2 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Change From Baseline Hamilton Anxiety Rating Scale 14-item Scale
|
3.67 score on a scale
Standard Deviation 2.52
|
4.40 score on a scale
Standard Deviation 4.22
|
6.50 score on a scale
Standard Deviation 4.95
|
3.37 score on a scale
Standard Deviation 4.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 WeeksPopulation: Two CFM, Placebo, two RFM, Placebo, and two CFM, Escitalopram participants did not complete the CGI at Week 8, and so their change from baseline CGI score could not be calculated.
Scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The Clinical Global Impressions correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points. 7-point scale: 0 = Not assessed 4 = Moderately ill 1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients
Outcome measures
| Measure |
Clinical Frequency Management: Placebo
n=3 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=5 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=3 Participants
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 Participants
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Change From Baseline Clinical Global Impressions
|
1.00 score on a scale
Standard Deviation 1.73
|
1.20 score on a scale
Standard Deviation 0.84
|
0.67 score on a scale
Standard Deviation 1.15
|
1.50 score on a scale
Standard Deviation 1.31
|
Adverse Events
Clinical Frequency Management: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Research Frequency Management: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Clinical Frequency Management: Escitalopram
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Research Frequency Management: Escitalopram
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinical Frequency Management: Placebo
n=5 participants at risk
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=7 participants at risk
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=5 participants at risk
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 participants at risk
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Dehydration
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
Other adverse events
| Measure |
Clinical Frequency Management: Placebo
n=5 participants at risk
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Research Frequency Management: Placebo
n=7 participants at risk
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Placebo: A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
|
Clinical Frequency Management: Escitalopram
n=5 participants at risk
Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
Research Frequency Management: Escitalopram
n=8 participants at risk
Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. If they respond, will be treated in a 3-month Continuation Phase with monthly site visits.
Escitalopram: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anorexia
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Body Pain
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
28.6%
2/7 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
25.0%
2/8 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Diaphoresis
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
50.0%
4/8 • Number of events 15 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
20.0%
1/5 • Number of events 6 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Drowsiness
|
20.0%
1/5 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
20.0%
1/5 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Dry Mouth
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
42.9%
3/7 • Number of events 5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Psychiatric disorders
Excitement
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
20.0%
1/5 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
25.0%
2/8 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Headache
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
28.6%
2/7 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Insomnia
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Psychiatric disorders
Memory Loss
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Reproductive system and breast disorders
Orgasm Delay
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 4 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
25.0%
2/8 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
20.0%
1/5 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
25.0%
2/8 • Number of events 3 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
14.3%
1/7 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
28.6%
2/7 • Number of events 2 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
Psychiatric disorders
Vivid Dreams
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Weakness
|
20.0%
1/5 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/8 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
|
General disorders
Weight Gain
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/7 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
0.00%
0/5 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
12.5%
1/8 • Number of events 1 • Subjects were monitored over a period of 8 weeks.
Subjects in the CFM group were evaluated by study personnel no less frequently than every 2 weeks for 8 weeks. Subjects were monitored for adverse effects, and dose adjustments will be made if indicated during this period of time.
|
Additional Information
Dr. Bret Rutherford
New York State Psychiatric Institute
Phone: 646-774-8660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place