At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,169 enrolled
Drug / intervention
Lamotrigine + Aripiprazole +1 moredrug
Likely dose
Lamotrigine + Aripiprazole 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 16, 2006·Updated May 13, 2026
In Brief
A Phase 4 clinical trial evaluating Lamotrigine + Aripiprazole and Lamotrigine + Placebo for Bipolar Disorder. Completed, enrolled 1,169 participants across 66 sites in 2 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesPuerto Rico, United States
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedJan 2006
Primary CompletionJul 2009
TodayJul 2026
First PostedJan 16, 2006
Enrollment StartDec 1, 2005
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.5 years ago
Interventions
Lamotrigine + Aripiprazoledrug
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
Lamotrigine + Placebodrug
Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day