Aripiprazole Treatment of Bipolar Depression
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression|
- Hamilton Depression Scale
|Study Start Date:||August 2005|
|Study Completion Date:||November 2006|
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 Hamilton Depression Rating Scale (HAM-D) during an 8-week treatment course.
a. Study Population:
A total number of 10 evaluable patients will be enrolled in the study.
c. Study Design and Method
This proposal will use an open label design. Aripiprazole will be added to the treatment of patients with DSM-IV (American Psychiatric Association, 1994) BDD. Patients will be allowed to continue their psychotropic medication, at a stable dose, as long as they meet inclusion criteria as described below. Aripiprazole will be started at a dose of 10 mg for two weeks, 15 mg for an additional two weeks, and 20 mg for the last four weeks. The length of time a patient stays on the maximum dose (20 mg) depends upon the patient's tolerance and treatment response. Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale (HAM-D 17) and other ratings scales.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198198
|United States, Indiana|
|UH 3124 University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Amit Anand, MD||Indiana University School of Medicine|