NCT00277212

A Phase IV Study of the Safety and Efficacy 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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,169 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-01-16
• Last updated: 2013-12-02
• Results posted: 2010-10-20

Locations

66 sites across 2 countries: United States, Puerto Rico