Conditions: Bipolar Disorder
Keywords: Lamotrigine Prevention of relapse or recurrence of a mood episode Bipolar I disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief summary:
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: lamotrigine 100mg/day or 200mg/day intervention 2: placebo once daily

Protocol document: