Conditions: Bipolar 1 Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 309
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.

Detailed description:

Arms:
arm 1: Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks arm 2: Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks

Interventions: intervention 1: ELND005 intervention 2: Lamotrigine intervention 3: Valproic acid intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: