Official Title: “Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy”

The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Study Type: Interventional

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

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: Lithium or Valproate with PBO
  • Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily
• Drug: Lithium or Valproate with Aripiprazole
  • Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A1
  • /Active Comparator
• Experimental: A2

Primary Measures

• Any mood episode
  • Time Frame: The time from randomization to relapse
    Safety Issue?: No

Secondary Measures

• Mean change in the Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (mania)
  • Time Frame: from baseline (end of Phase 2) to endpoint (Week 52 LOCF)
    Safety Issue?: No

Inclusion Criteria:

• Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for
• Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00261443

Study ID Number: CN138-189

ClinicalTrials.gov Identifier: NCT00261443

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm