A Phase 4 interventional study of Aripiprazole in Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment
)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 32 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
Drug: Aripiprazole
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Primary Measure:Reduction in Depression Symptoms
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).
Time frame: up to 12 weeks
Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.
| Milestone | Aripiprazole Plus Divalproex ER |
|---|---|
| Started | 32 |
| Completed | 10 |
| Not completed | 22 |
| Withdrew: Screen failure | 9 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 2 |
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).
| participants | Aripiprazole Plus Divalalproex ER |
|---|---|
| Primary Measure:Reduction in Depression Symptoms | 16 |
Collected over 3-31-2006 to 9-11-2009, 3 yrs 6 mo. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aripiprazole Plus Divalproex ER | — | 0/19 (0%) | 6/16 (37.5%) |
| Event | Aripiprazole Plus Divalproex ER |
|---|---|
| AkathisiaNervous system disorders | 6/16 |
32 subjects consented, 19 subjects were baselined
| Age, Categorical(Participants) | Aripiprazole |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Age, Continuous(years) | Aripiprazole |
|---|---|
| Mean | 41 ± 10.0 |
| Sex: Female, Male(Participants) | Aripiprazole |
|---|---|
| Female | 13 |
| Male | 6 |
| Region of Enrollment(participants) | Aripiprazole |
|---|---|
| United States | 19 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio