Trial Outcomes & Findings for A Study of Aripiprazole in Patients With Major Depressive Disorder (NCT NCT00105196)
NCT ID: NCT00105196
Last Updated: 2013-12-02
Results Overview
Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
349 participants
Primary outcome timeframe
Baseline (Week 8) and Week 14
Results posted on
2013-12-02
Participant Flow
After initial screening period (7-28 days), subjects enrolled into an 8-wk prospective treatment phase (single-blind placebo plus an investigator-assigned, open-label, marketed antidepressant therapy \[ADT\]). Patients who met criteria for incomplete response at the end of this phase were randomized into the 6-wk double-blind phase in a 1:1 ratio.
Participant milestones
| Measure |
Aripiprazole + ADT
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
172
|
|
Overall Study
COMPLETED
|
147
|
149
|
|
Overall Study
NOT COMPLETED
|
30
|
23
|
Reasons for withdrawal
| Measure |
Aripiprazole + ADT
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Adverse Event
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Poor/noncompliance
|
3
|
4
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
pending surgery
|
0
|
1
|
|
Overall Study
marijuana use
|
0
|
1
|
|
Overall Study
Subject became unblinded
|
0
|
1
|
Baseline Characteristics
A Study of Aripiprazole in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Aripiprazole + ADT
n=177 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=172 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
155 participants
n=5 Participants
|
149 participants
n=7 Participants
|
304 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 8) and Week 14Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole + ADT
n=174 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=169 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
|
-10.12 units on a scale
Standard Error 0.74
|
-6.39 units on a scale
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Baseline (Week 8) and Week 14Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Mean Change in Sheehan Disability Scale (SDS) Mean Score
|
-1.22 units on a scale
Standard Error 0.21
|
-0.80 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline (Week 8) and Week 14Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Mean Change in SDS Item Score (Social Life)
|
-1.18 units on a scale
Standard Error 0.24
|
-0.65 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline (Week 8) and Week 14Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=160 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Mean Change in SDS Item Score (Family Life)
|
-1.39 units on a scale
Standard Error 0.24
|
-0.82 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline (Week 8) and Week 14Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Outcome measures
| Measure |
Aripiprazole + ADT
n=115 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=126 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Mean Change in SDS Item Score (Work/School)
|
-0.75 units on a scale
Standard Error 0.28
|
-0.67 units on a scale
Standard Error 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 8) and Week 14Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).
Outcome measures
| Measure |
Aripiprazole + ADT
n=174 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=169 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
MADRS Response
Responders
|
81 participants
|
45 participants
|
|
MADRS Response
Nonresponders
|
93 participants
|
124 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 8) and Week 14Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).
Outcome measures
| Measure |
Aripiprazole + ADT
n=174 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=169 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
Clinical Global Impression (CGI)-Improvement Response
Responders
|
109 Participants
|
74 Participants
|
|
Clinical Global Impression (CGI)-Improvement Response
Nonresponders
|
65 Participants
|
95 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 8) and Week 14Number of subjects in remission. Remission defined as as MADRS Total Score of \<10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).
Outcome measures
| Measure |
Aripiprazole + ADT
n=174 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
Placebo + ADT
n=169 Participants
Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
|
|---|---|---|
|
MADRS Remission
No remission
|
110 participants
|
137 participants
|
|
MADRS Remission
Remission
|
64 participants
|
32 participants
|
Adverse Events
Aripiprazole
Serious events: 1 serious events
Other events: 107 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=176 participants at risk
|
Placebo
n=172 participants at risk
|
|---|---|---|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/176
|
0.58%
1/172
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.57%
1/176
|
0.00%
0/172
|
Other adverse events
| Measure |
Aripiprazole
n=176 participants at risk
|
Placebo
n=172 participants at risk
|
|---|---|---|
|
Eye disorders
VISION BLURRED
|
7.4%
13/176
|
1.7%
3/172
|
|
Psychiatric disorders
INSOMNIA
|
8.5%
15/176
|
5.2%
9/172
|
|
Psychiatric disorders
RESTLESSNESS
|
12.5%
22/176
|
3.5%
6/172
|
|
Nervous system disorders
HEADACHE
|
8.5%
15/176
|
8.1%
14/172
|
|
Nervous system disorders
AKATHISIA
|
18.2%
32/176
|
3.5%
6/172
|
|
Nervous system disorders
DIZZINESS
|
5.1%
9/176
|
2.9%
5/172
|
|
Nervous system disorders
SOMNOLENCE
|
5.7%
10/176
|
0.58%
1/172
|
|
Gastrointestinal disorders
NAUSEA
|
4.0%
7/176
|
5.8%
10/172
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.7%
10/176
|
7.6%
13/172
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.7%
10/176
|
3.5%
6/172
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.4%
13/176
|
7.6%
13/172
|
|
General disorders
FATIGUE
|
9.1%
16/176
|
4.7%
8/172
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER