Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT00257192

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

284

Starts

2006-04-01

Expected to finish

2009-03-01

Last updated by the study team

2021-03-25

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Stanford, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Altamonte Springs, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — North Miami, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Tavares, Florida, United States
• Pfizer Investigational Site — Smyrna, Georgia, United States
• Pfizer Investigational Site — Tucker, Georgia, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Des Plaines, Illinois, United States
• Pfizer Investigational Site — Oakbrook Terrace, Illinois, United States
• Pfizer Investigational Site — Schaumburg, Illinois, United States
• Pfizer Investigational Site — Pikesville, Maryland, United States
• Pfizer Investigational Site — Towson, Maryland, United States
• Pfizer Investigational Site — Towson, Maryland, United States
• Pfizer Investigational Site — Clinton Township, Michigan, United States
• Pfizer Investigational Site — Meridian, Mississippi, United States
• Pfizer Investigational Site — Bridgeton, Missouri, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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