Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2004

Last Updated Date

June 27, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change on a depression rating scale at endpoint

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00080314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response rate and Clinical Global Impression scale at endpoint

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Brief Summary

The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Aripiprazole
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

ages 18-65
Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00080314

Responsible Party

Study ID Numbers ^ICMJE

CN138-096

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Otsuka America Pharmaceutical

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP