Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Key facts

Study ID

NCT00406315

Run by

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

People needed

255

Starts

2006-11-01

Expected to finish

2009-03-01

Last updated by the study team

2021-03-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, between 18 and 55 years of age, at the time of consent.
• Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
• Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

You may not qualify if…

• Subjects who are unable to provide informed consent
• Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
• Females who are pregnant, breast feeding, or lactating at screening.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Garden Grove, California, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Temecula, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Hialeah, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, 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 — Topeka, Kansas, United States
• Pfizer Investigational Site — Olive Branch, Mississippi, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Las Vegas, Nevada, United States
• Pfizer Investigational Site — Nashua, New Hampshire, United States
• Pfizer Investigational Site — Olean, New York, United States
• Pfizer Investigational Site — Staten Island, New York, United States
• Pfizer Investigational Site — Memphis, Tennessee, United States
• Pfizer Investigational Site — Memphis, Tennessee, United States
• Pfizer Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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