Conditions: Bipolar Depression
Keywords: Bipolar I Latuda Lurasidone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 348
Healthy volunteers: no

Brief summary:
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: lurasidone + (lithium or divalproex) intervention 2: Placebo + (lithium or divalproex)
Intervention descriptions: intervention 1: lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. intervention 2: 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

Protocol document: