12- Week Open Label Treatment of Refractory Bipolar Depression

Study Overview
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Brief Summary
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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 Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Detailed Description
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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

Official Title
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12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of bipolar disorder I or II according to M.I.N.I. patient has signed informed consent male, or female who is using effective birth control if of child bearing age age 18 and above currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria score of more than 19 on the MADRS history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant Exclusion Criteria: current liver disease, illness precluding the use of depakote er patients who have been treated with a DEP and AZP combination in the past Alcohol/drug dependence in the past one month CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma thyroid dysfunction unstable general medical condition require antipsychotic other than abilify

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD. | Drug: Aripiprazole<br>* Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Depression, Refractory