Conditions: Bipolar Disorder
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 169
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Ziprasidone oral capsules
Intervention descriptions: intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Protocol document: