Status:
TERMINATED
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
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
Detailed 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 DS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00257192
Start Date
April 1 2006
End Date
March 1 2009
Last Update
March 25 2021
Active Locations (92)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-4400
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
4
Pfizer Investigational Site
San Diego, California, United States, 92123