A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country255 target enrollmentNovember 2006

ConditionsSchizophrenia Schizoaffective Disorder

Interventionsziprasidone

Drugsziprasidone

Overview

Phase: Phase 4
Intervention: ziprasidone
Conditions: Schizophrenia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 255
Locations: 1
Primary Endpoint: Change From Baseline in Weight at Week 16
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

March 2009

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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.

Exclusion Criteria

•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.

Arms & Interventions

A1

atypical antipsychotic for the treatment of schizophrenia

Intervention: ziprasidone

Outcomes

Primary Outcomes

Change From Baseline in Weight at Week 16

Time Frame: Baseline, Week 16, Week 16 LOCF

Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.

Secondary Outcomes

Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16(Baseline, Week 16)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16(Baseline, Week 16)
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16(Baseline, Week 16, Week 16 LOCF)
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16(Baseline, Week 16, Week 16 LOCF)
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16(Baseline, Week 16, Week 16 LOCF)
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16(Baseline, Week 16)
Change From Baseline in Fasting Glucose at Week 16(Baseline, Week 16)
Change From Baseline in Waist and Hip Circumference at Week 16(Baseline, Week 16)
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16(Baseline, Week 16, Week 16 LOCF)
Change From Baseline in Fasting Insulin at Week 16(Baseline, Week 16)
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16(Week 16, Week 16 LOCF)
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16(Baseline, Week 16)
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16(Baseline, Week 16, Week 16 LOCF)
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16(Baseline, Week 16, Week 16 LOCF)