Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia
Full description
Termination Reason: 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.
- At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.
- Age 13 - 17 years
Exclusion criteria
- Imminent risk of suicide or homicide, as judged by the site investigator
- Any history of serious or unstable medical illness, including risk for QT prolongation
Trial design
Primary purpose
Allocation
Interventional model
Masking
284 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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