Conditions: Bipolar Disorder
Keywords: Open-label extension Tolerability Lamotrigine Safety Bipolar I disorder
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 92
Healthy volunteers: no

Brief summary:
This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase.

Detailed description:

Arms:
arm 1: study drug

Interventions: intervention 1: BW430C (lamotrigine)
Intervention descriptions: intervention 1: lamotrigine 50mg/day-400mg/day

Protocol document: