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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
2) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Aripiprazole5mg - 30mg, every day (QD), for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Singh, MD | University of Texas | Principal Investigator |
| Charles L Bowden, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Texas Helath Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
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.
Recruitment from March 2006 to June 2009 from clinic patients and those responding to public advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
32 subjects consented, 19 subjects were baselined
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | up to 12 weeks |
|
3-31-2006 to 9-11-2009, 3 yrs 6 mo
Patient reporting and systematic questioning
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | Systematic Assessment | a feeling of restlessness that results in movements of body parts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Bowden | UTHSCSA | 210-567-5479 | Bowdenc@uthscsa.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Withdrawal by Subject |
|
| Physician Decision |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 19 |
| 6 |
| 16 |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |