Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1270
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

Detailed description:

Arms:
arm 1: /Active Comparator arm 2: None

Interventions: intervention 1: Lithium or Valproate with placebo (PBO) intervention 2: Lithium or Valproate with Aripiprazole
Intervention descriptions: intervention 1: Tablets, Oral, once daily

lithium 250-2100 mg/day

valproate 250-2500mg/day

Placebo once daily intervention 2: Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)

lithium 250-2100 mg/day

valproate 250-2500mg/day

aripiprazole 15-30 mg/day

Protocol document: