Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1169
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole arm 2: Phase 2 Double-Blind Treatment: Lamotrigine + Placebo

Interventions: intervention 1: Lamotrigine + Aripiprazole intervention 2: Lamotrigine + Placebo
Intervention descriptions: intervention 1: 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 intervention 2: Tablets, Oral, once daily, Phase 2 - up to 52 weeks

Lamotrigine 100-200 mg/day

placebo 0 mg/day

Protocol document: