Conditions: Bipolar Disorder Mania
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 493
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

Detailed description:

Arms:
arm 1: Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. arm 2: Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.

Interventions: intervention 1: Aripiprazole intervention 2: Placebo intervention 3: Lithium intervention 4: Valproate
Intervention descriptions: intervention 1: 5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 12 weeks intervention 3: Participant's ongoing dose intervention 4: Participant's ongoing dose

Protocol document: