Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Cambridge Health Alliance1 site in 1 country20 target enrollmentApril 2004

ConditionsBipolar Disorder

InterventionsAripiprazole

DrugsAripiprazole

Overview

Phase: Not Applicable
Intervention: Aripiprazole
Conditions: Bipolar Disorder
Sponsor: Cambridge Health Alliance
Enrollment: 20
Locations: 1
Primary Endpoint: Depression state
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Detailed Description

Study is 6 weeks long with 7 clinical visits.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

February 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cambridge Health Alliance

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•DSM-IV diagnosis of bipolar disorder, any subtype; MADRS \>16; MRS \< 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria

•Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations