Trial Outcomes & Findings for Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (NCT NCT02960763)
NCT ID: NCT02960763
Last Updated: 2024-10-03
Results Overview
Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
742 participants
Primary outcome timeframe
Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Results posted on
2024-10-03
Participant Flow
Patients were recruited based on referrals from primary care providers (PCPs) or psychiatrists and self-referrals. This was further checked by using tools electronic medical records (EMRs) and using EMR-launched clinical decision tools. Print, radio, and social media advertising were used too. If patients self-referred, treatment recommendations were given by their community providers or a psychiatrist associated with the study.
Participant milestones
| Measure |
Aripiprazole Augmentation
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Step 1
STARTED
|
211
|
206
|
202
|
0
|
0
|
|
Step 1
COMPLETED
|
192
|
188
|
174
|
0
|
0
|
|
Step 1
NOT COMPLETED
|
19
|
18
|
28
|
0
|
0
|
|
Step 2
STARTED
|
0
|
0
|
0
|
127
|
121
|
|
Step 2
People Who Participated in Step 1 and Continued to Participate in Step 2
|
43
|
44
|
38
|
0
|
0
|
|
Step 2
People Who Began Step 2 Without Having Participated in Step 1
|
0
|
0
|
0
|
63
|
60
|
|
Step 2
COMPLETED
|
0
|
0
|
0
|
116
|
116
|
|
Step 2
NOT COMPLETED
|
0
|
0
|
0
|
11
|
5
|
Reasons for withdrawal
| Measure |
Aripiprazole Augmentation
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Step 1
Withdrawal by Subject
|
10
|
8
|
13
|
0
|
0
|
|
Step 1
Lost to Follow-up
|
7
|
9
|
12
|
0
|
0
|
|
Step 1
Death
|
1
|
1
|
1
|
0
|
0
|
|
Step 1
Investigator discretion
|
1
|
0
|
1
|
0
|
0
|
|
Step 1
Other
|
0
|
0
|
1
|
0
|
0
|
|
Step 2
Withdrawal by Subject
|
0
|
0
|
0
|
7
|
3
|
|
Step 2
Lost to Follow-up
|
0
|
0
|
0
|
4
|
1
|
|
Step 2
Investigator discretion
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Step 1 had 619 participants enrolled
Baseline characteristics by cohort
| Measure |
Aripiprazole Augmentation
n=211 Participants
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 Participants
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 Participants
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 Participants
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 Participants
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
Total
n=867 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.07 years
STANDARD_DEVIATION 6.46 • n=211 Participants • Step 1 had 619 participants enrolled
|
69.13 years
STANDARD_DEVIATION 7.14 • n=206 Participants • Step 1 had 619 participants enrolled
|
69.68 years
STANDARD_DEVIATION 7.71 • n=202 Participants • Step 1 had 619 participants enrolled
|
—
|
—
|
69.29 years
STANDARD_DEVIATION 7.10 • n=619 Participants • Step 1 had 619 participants enrolled
|
|
Age, Customized
|
—
|
—
|
—
|
69.04 years
STANDARD_DEVIATION 6.00 • n=127 Participants • Step 2 had 248 participants enrolled
|
68.03 years
STANDARD_DEVIATION 5.72 • n=121 Participants • Step 2 had 248 participants enrolled
|
68.55 years
STANDARD_DEVIATION 5.88 • n=248 Participants • Step 2 had 248 participants enrolled
|
|
Sex: Female, Male
Female
|
144 Participants
n=211 Participants • Step 1 totals for sex of participants enrolled
|
142 Participants
n=206 Participants • Step 1 totals for sex of participants enrolled
|
127 Participants
n=202 Participants • Step 1 totals for sex of participants enrolled
|
90 Participants
n=127 Participants • Step 2 sex of participants enrolled
|
83 Participants
n=121 Participants • Step 2 sex of participants enrolled
|
173 Participants
n=248 Participants • Step 2 sex of participants enrolled
|
|
Sex: Female, Male
Male
|
67 Participants
n=211 Participants • Step 1 totals for sex of participants enrolled
|
64 Participants
n=206 Participants • Step 1 totals for sex of participants enrolled
|
75 Participants
n=202 Participants • Step 1 totals for sex of participants enrolled
|
37 Participants
n=127 Participants • Step 2 sex of participants enrolled
|
38 Participants
n=121 Participants • Step 2 sex of participants enrolled
|
75 Participants
n=248 Participants • Step 2 sex of participants enrolled
|
|
Race/Ethnicity, Customized
White
|
173 Participants
n=211 Participants • Step 1 race/ethnicity of participants enrolled
|
174 Participants
n=206 Participants • Step 1 race/ethnicity of participants enrolled
|
175 Participants
n=202 Participants • Step 1 race/ethnicity of participants enrolled
|
116 Participants
n=127 Participants • Step 2 race/ethnicity of participants enrolled
|
106 Participants
n=121 Participants • Step 2 race/ethnicity of participants enrolled
|
222 Participants
n=248 Participants • Step 2 race/ethnicity of participants enrolled
|
|
Race/Ethnicity, Customized
African American
|
16 Participants
n=211 Participants • Step 1 race/ethnicity of participants enrolled
|
17 Participants
n=206 Participants • Step 1 race/ethnicity of participants enrolled
|
13 Participants
n=202 Participants • Step 1 race/ethnicity of participants enrolled
|
7 Participants
n=127 Participants • Step 2 race/ethnicity of participants enrolled
|
4 Participants
n=121 Participants • Step 2 race/ethnicity of participants enrolled
|
11 Participants
n=248 Participants • Step 2 race/ethnicity of participants enrolled
|
|
Race/Ethnicity, Customized
Other
|
189 Participants
n=211 Participants • Step 1 race/ethnicity of participants enrolled
|
189 Participants
n=206 Participants • Step 1 race/ethnicity of participants enrolled
|
189 Participants
n=202 Participants • Step 1 race/ethnicity of participants enrolled
|
124 Participants
n=127 Participants • Step 2 race/ethnicity of participants enrolled
|
111 Participants
n=121 Participants • Step 2 race/ethnicity of participants enrolled
|
235 Participants
n=248 Participants • Step 2 race/ethnicity of participants enrolled
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
22 Participants
n=211 Participants • Step 1 race/ethnicity of participants enrolled
|
17 Participants
n=206 Participants • Step 1 race/ethnicity of participants enrolled
|
13 Participants
n=202 Participants • Step 1 race/ethnicity of participants enrolled
|
3 Participants
n=127 Participants • Step 2 race/ethnicity of participants enrolled
|
10 Participants
n=121 Participants • Step 2 race/ethnicity of participants enrolled
|
13 Participants
n=248 Participants • Step 2 race/ethnicity of participants enrolled
|
PRIMARY outcome
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeksPsychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10).
Outcome measures
| Measure |
Aripiprazole Augmentation
n=211 Participants
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 Participants
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 Participants
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 Participants
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 Participants
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Psychological Well-Being
baseline
|
34.7 t-score
Interval 33.8 to 35.6
|
35.0 t-score
Interval 34.1 to 36.0
|
34.8 t-score
Interval 33.8 to 35.7
|
33.1 t-score
Interval 31.9 to 34.4
|
34.2 t-score
Interval 32.9 to 35.4
|
|
Psychological Well-Being
10 weeks
|
38.8 t-score
Interval 37.9 to 39.8
|
38.7 t-score
Interval 37.8 to 39.7
|
36.1 t-score
Interval 35.1 to 37.2
|
35.7 t-score
Interval 34.4 to 37.1
|
35.6 t-score
Interval 34.3 to 37.0
|
PRIMARY outcome
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeksRemission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Outcome measures
| Measure |
Aripiprazole Augmentation
n=211 Participants
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 Participants
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 Participants
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 Participants
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 Participants
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Number of Participants With Remission From Depression
|
61 Participants
|
58 Participants
|
39 Participants
|
24 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeksLife threatening illness, hospitalization, or need of medical care.
Outcome measures
| Measure |
Aripiprazole Augmentation
n=211 Participants
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 Participants
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 Participants
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 Participants
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 Participants
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Serious Adverse Events
|
15 Participants
|
15 Participants
|
19 Participants
|
12 Participants
|
11 Participants
|
Adverse Events
Aripiprazole Augmentation
Serious events: 15 serious events
Other events: 148 other events
Deaths: 1 deaths
Bupropion Augmentation
Serious events: 15 serious events
Other events: 120 other events
Deaths: 1 deaths
Switch to Bupropion
Serious events: 19 serious events
Other events: 136 other events
Deaths: 1 deaths
Lithium Augmentation
Serious events: 12 serious events
Other events: 93 other events
Deaths: 0 deaths
Switch to Nortriptyline
Serious events: 11 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole Augmentation
n=211 participants at risk
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 participants at risk
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 participants at risk
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 participants at risk
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 participants at risk
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
0.00%
0/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.5%
3/206 • Number of events 3 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.7%
2/121 • Number of events 2 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Non-psychiatric Hospitalization
|
6.6%
14/211 • Number of events 14 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.3%
11/206 • Number of events 11 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.4%
17/202 • Number of events 22 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.4%
12/127 • Number of events 13 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
6.6%
8/121 • Number of events 8 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Fall
|
0.00%
0/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.83%
1/121 • Number of events 1 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Other
|
0.47%
1/211 • Number of events 1 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.50%
1/202 • Number of events 1 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
Other adverse events
| Measure |
Aripiprazole Augmentation
n=211 participants at risk
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Aripiprazole Augmentation: Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
|
Bupropion Augmentation
n=206 participants at risk
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Bupropion Augmentation: Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Switch to Bupropion
n=202 participants at risk
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to bupropion: Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
|
Lithium Augmentation
n=127 participants at risk
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Lithium Augmentation: Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
|
Switch to Nortriptyline
n=121 participants at risk
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.
Switch to nortriptyline: Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Akathisia
|
10.9%
23/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.97%
2/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
2.5%
5/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.6%
2/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Headache
|
7.6%
16/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.3%
17/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.4%
15/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
10.2%
13/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.0%
6/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Reduced Salivation
|
7.1%
15/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
14.6%
30/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
11.4%
23/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
10.2%
13/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
42.1%
51/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
7.1%
15/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
12.1%
25/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
15.3%
31/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.4%
12/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.4%
9/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
6.6%
14/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.8%
12/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.4%
11/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
6.3%
8/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.8%
7/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
15/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.7%
20/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.9%
18/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
4.7%
6/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
16.5%
20/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Weight gain
|
15.2%
32/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.5%
3/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.50%
1/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
6.3%
8/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.3%
4/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Cold/Flu Symptoms
|
13.7%
29/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.7%
18/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
11.4%
23/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
10.2%
13/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
10.7%
13/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Dizziness
|
17.1%
36/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
19.9%
41/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
19.8%
40/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
22.0%
28/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
17.4%
21/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Fall
|
5.2%
11/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.8%
16/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.4%
15/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.9%
10/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
4.1%
5/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Increased Appetite Without Weight Gain
|
10.9%
23/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.97%
2/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.0%
6/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.6%
2/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.0%
6/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Psychiatric disorders
Irritability or Emotional Lability
|
4.7%
10/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.8%
12/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
16.8%
34/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.9%
5/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
12.4%
15/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Psychiatric disorders
Concenctration Difficulties
|
5.2%
11/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.9%
4/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.0%
10/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.1%
9/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.3%
10/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Asthenia/Lassitude/Increased Fatiguability
|
8.5%
18/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.3%
11/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.5%
3/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
14.2%
18/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.1%
11/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Sleepiness/Sedation
|
9.5%
20/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
4.4%
9/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
1.5%
3/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.7%
11/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.9%
12/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Tension/Inner Unrest
|
14.2%
30/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.7%
20/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
14.4%
29/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
6.3%
8/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
7.4%
9/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Tremor
|
6.6%
14/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
9.7%
20/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
6.4%
13/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
26.8%
34/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.3%
4/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
Renal and urinary disorders
Polyuria/Polydipsia
|
2.4%
5/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.00%
0/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.0%
6/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
8.7%
11/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
0.83%
1/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
|
General disorders
Increased Tendency to Sweating
|
2.4%
5/211 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
3.9%
8/206 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
2.5%
5/202 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
2.4%
3/127 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
5.0%
6/121 • Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.
This study assessed adverse events (in particular falls) to determine how safe and tolerable the treatments were. This was done because it is important for doctors to be able to cite safety concerns as one of the main restrictions in treatment of depression in older adults. One challenge with the rates of AE's/SAE's was because of the naturally high rate of medical problems and falls in depressed older adults. Most of the SAE's reported were decided to not be related to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place