Conditions: Bipolar Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ziprasidone oral capsules intervention 2: placebo oral capsules
Intervention descriptions: intervention 1: Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. intervention 2: Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Protocol document: