Status:
COMPLETED
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00406315
Start Date
November 1 2006
End Date
March 1 2009
Last Update
March 29 2021
Active Locations (40)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85028
2
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
3
Pfizer Investigational Site
Garden Grove, California, United States, 92845
4
Pfizer Investigational Site
National City, California, United States, 91950