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

Recruiting at37 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

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.

Treatment Details

Interventions

• Ziprasidone (Atypical Antipsychotic)

Participant Groups

Group I: A1 Experimental Treatment 1 Intervention

atypical antipsychotic for the treatment of schizophrenia

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

435

Recruited

407,000+

Dr. Sanjeev Narula

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

Chief Medical Officer

MD from Harvard Medical School

Scott A. Smith

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

Chief Executive Officer since 2023

BSc in Chemistry and Biology, Honors BSc in Pharmacology and Toxicology from Western University, MBA from Thunderbird School of Global Management