Status:
COMPLETED
Aripiprazole Treatment of Bipolar Depression
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving.
Detailed Description
Hypothesis/Objectives: Aim 1: To investigate whether aripiprazole is effective in the treatment of bipolar depression. Hypothesis 1: Aripiprazole will lead to a significant decrease in scores on the...
Eligibility Criteria
Inclusion
- 1\) Male or female between 18 - 65 years of age, inclusive 2) Satisfy DSM-IV criteria for bipolar disorder depressed phase i.e.,duration of depression \> 2 weeks) 3) No change in psychotropic medication or their doses within 2 weeks of inclusion in The study. 4) Inadequately responsive to or intolerant of prior pharmacotherapy as determined by the investigator 5) 17-item Hamilton Depression Rating Scale Score \> 15 6) Young Mania Rating Scale (Young, et. al., 1978) (YMRS) \< 10.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00198198
Start Date
August 1 2005
End Date
November 1 2006
Last Update
April 5 2007
Active Locations (1)
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1
UH 3124 University Hospital
Indianapolis, Indiana, United States, 46202