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NCT00094432 Clinical Trial

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

Bipolar I 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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00094432
Other study ID # CN138-146
Secondary ID
Status Completed
Phase Phase 3
First received October 18, 2004
Last updated November 7, 2013
Start date June 2004
Est. completion date November 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 several doses of aripiprazole in patients with bipolar depression.

Recruitment information / eligibility
Status Completed
Enrollment 650
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Men and women, ages 18-65

- Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, 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 Alburquerque New Mexico
United States Local Institution Baltimore Maryland
United States Local Institution Bellevue Washington
United States Local Institution Brooklyn New York
United States Local Institution Charleston West Virginia
United States Local Institution Charlottesville Virginia
United States Local Institution Clementon New Jersey
United States Local Institution Columbia South Carolina
United States Local Institution Coral Springs Florida
United States Local Institution Dayton Ohio
United States Local Institution Desoto Texas
United States Local Institution Edwardsville Illinois
United States Local Institution Elmsford New York
United States Local Institution Houston Texas
United States Local Institution Jacksonville Florida
United States Local Institution La Mesa California
United States Local Institution La Palma California
United States Local Institution Lafayette Indiana
United States Local Institution Long Beach California
United States Local Institution Marietta Georgia
United States Local Institution Media Pennsylvania
United States Local Institution Mesa Arizona
United States Local Institution Midlothian Virginia
United States Local Institution New Orleans Louisiana
United States Local Institution New York New York
United States Local Institution Newton Kansas
United States Local Institution Oak Brook Illinois
United States Local Institution Philadelphia Pennsylvania
United States Local Institution Pittsburgh Pennsylvania
United States Local Institution Raleigh North Carolina
United States Local Institution Redlands California
United States Local Institution Salt Lake City Utah
United States Local Institution San Diego California
United States Local Institution Sherman Oaks California
United States Local Institution Shreveport Louisiana
United States Local Institution Springfield Illinois
United States Local Institution St. Louis Missouri
United States Local Institution St. Petersburg Florida
United States Local Institution Washington District of Columbia
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 Mean change from baseline to endpoint on the MADRS total score.
Secondary Clinical Global Impression - Bipolar Version
Secondary Severity of illness score depression
Secondary Mean change from baseline to endpoint
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Active, not recruiting NCT04561622 - Emotional Proactive Processing in Bipolar Disorder
Recruiting NCT03943537 - Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders Phase 2
Completed NCT03334721 - Gabapentin for Bipolar & Cannabis Use Disorders Phase 2
Active, not recruiting NCT05658510 - Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) Phase 3

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