Conditions: Schizophrenia
Keywords: Adolescent Subjects
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 221
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 adolescents (ages 13-17) with schizophrenia.

Detailed description:
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

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: