12- Week Open Label Treatment of Refractory Bipolar Depression
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|ClinicalTrials.gov Identifier: NCT00223496|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 21, 2013
Last Update Posted : May 16, 2017
- 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
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Aripiprazole||Phase 4|
)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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
- Primary Measure:Reduction in Depression Symptoms [ Time Frame: up to 12 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223496
|United States, Texas|
|Univ of Texas Helath Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Vivek Singh, MD||University of Texas|
|Principal Investigator:||Charles L Bowden, MD||University of Texas|