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NCT00080314 Clinical Trial

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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00080314
Other study ID # CN138-096
Secondary ID
Status Completed
Phase Phase 3
First received March 26, 2004
Last updated November 7, 2013
Start date January 2004
Est. completion date October 2006

Study information
Verified date June 2008
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility - 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
• Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.

Locations
Country Name City State
United States Local Institution Arlington Virginia
United States Local Institution Austin Texas
United States Local Institution Beachwood Ohio
United States Local Institution Bellevue Washington
United States Local Institution Chicago Illinois
United States Local Institution Dallas Texas
United States Local Institution Dayton Ohio
United States Local Institution Durham North Carolina
United States Local Insstitution Honolulu Hawaii
United States Local Institution Houston Texas
United States Local Institution Jacksonville Florida
United States Local Institution Lake Charles Louisiana
United States Local Institution Lake Jackson Texas
United States Local Institution Little Rock Arkansas
United States Local Institution Maitland Florida
United States Local Institution Media Pennsylvania
United States Local Institution Memphis Tennessee
United States Local Institution Norwich Connecticut
United States Local Institution Oklahoma City Oklahoma
United States Local Institution Orlando Florida
United States Local Institution Portland Oregon
United States Local Institution Raleigh North Carolina
United States Local Institution Rockville Maryland
United States Local Institution San Diego California
United States Local Institution Sherman Oaks California
United States Local Institution Tuscaloosa Alabama
United States Local Institution West Haven Connecticut
United States Local Institution Wichita Falls Texas

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change on a depression rating scale at endpoint
Secondary Response rate and Clinical Global Impression scale at endpoint
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