Trial Outcomes & Findings for 12- Week Open Label Treatment of Refractory Bipolar Depression (NCT NCT00223496)
NCT ID: NCT00223496
Last Updated: 2017-05-16
Results Overview
Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).
COMPLETED
PHASE4
32 participants
up to 12 weeks
2017-05-16
Participant Flow
Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.
Subjects who entered study in a bipolar depressed state were started on divalproex ER. Those still depressed, according to depression rating scales, after visit 4 were given aripiprazole in addition to divalproex ER.
Participant milestones
| Measure |
Aripiprazole Plus Divalproex ER
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
|
|---|---|
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Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Aripiprazole Plus Divalproex ER
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
|
|---|---|
|
Overall Study
screen failure
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
12- Week Open Label Treatment of Refractory Bipolar Depression
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=19 Participants
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPrimary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).
Outcome measures
| Measure |
Aripiprazole Plus Divalalproex ER
n=16 Participants
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
|
|---|---|
|
Primary Measure:Reduction in Depression Symptoms
|
16 participants
|
Adverse Events
Aripiprazole Plus Divalproex ER
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole Plus Divalproex ER
n=16 participants at risk；n=19 participants at risk
Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
|
|---|---|
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Nervous system disorders
Akathisia
|
37.5%
6/16 • Number of events 6 • 3-31-2006 to 9-11-2009, 3 yrs 6 mo
Patient reporting and systematic questioning
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place