Official Title: “A Multicenter, Double-Blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode”

Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine + Aripiprazole
  • Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day Aripiprazole 10-30 mg/day
• Drug: Lamotrigine + Placebo
  • Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A1
• Placebo Comparator: A2

Primary Measures

• The primary efficacy measure will be the time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase (Phase 2)
  • Time Frame: up to 52 weeks maximum
    Safety Issue?: No

Secondary Measures

• Time to any relapse (manic, mixed, depressive) in the Double-blind Relapse Assessment Phase
  • Time Frame: up to 52 weeks maximum
    Safety Issue?: No
• Time to Depressive relapse, in the Double-blind Relapse Assessment Phase
  • Time Frame: up to 52 weeks maximum
    Safety Issue?: No
• Time to discontinuation for any reason in the Double-blind Relapse Assessment Phase
  • Time Frame: up to 52 weeks
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• First manic episode
• Current manic or mixed episode with > 2 years duration
• Treated with aripiprazole within the past 3 months
• Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

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 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277212

Study ID Number: CN138-392 ST

ClinicalTrials.gov Identifier: NCT00277212

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

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