NCT00198198

Aripiprazole Treatment of Bipolar Depression

Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Aripiprazole

Timeline

• Start date: 2005-08-01
• Completion: 2006-11-01
• First posted: 2005-09-20
• Last updated: 2007-04-05

Locations

1 site across 1 country: United States