NCT00223496

12- Week Open Label Treatment of Refractory Bipolar Depression

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1. 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

Detailed description

)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

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2005-09-22
• Last updated: 2017-05-16
• Results posted: 2013-05-21

Locations

1 site across 1 country: United States