Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site147 target enrollmentJanuary 2003

ConditionsSchizophrenia

InterventionsClozapine Ziprasidone

DrugsClozapine Ziprasidone

Overview

Phase: Phase 3
Intervention: Clozapine
Conditions: Schizophrenia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 147
Locations: 1
Primary Endpoint: Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

September 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•CGI - S ≥4
•PANSS ≥ 80
•Inpatients or outpatients

Exclusion Criteria

•Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug
•Diagnosis of substance dependence within previous 3 months using DSM-IV criteria
•History of seizure
•Organic mental disease, including mental retardation or epilepsy

Arms & Interventions

A

Intervention: Clozapine

B

Intervention: Ziprasidone

Outcomes

Primary Outcomes

Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores

Time Frame: Until Final Visit (within 18 weeks)

Secondary Outcomes

Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores(Baseline and weekly from Weeks 1-18)
Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test(Baseline and Weeks 12 and 18)
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores(Baseline and Weeks 4, 8, 12, and 18)
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores(Screening and Weeks 1, 8, 12, and 18)
Change from baseline to endpoint in PANSS subscale scores(Baseline and weekly from Weeks 1-18)
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores(Baseline and Weeks 8, 12, and 18)
Change from baseline in laboratory tests(Screening and weekly from Weeks 1-18)
Proportion of responders, based on change from baseline to endpoint in PANSS total score(Until Final Visit (within 18 weeks))
Time to discontinuation(Up to 18 weeks)
Change from baseline in Caregiver Activity Survey (CAS)(Screening and Weeks 1, 8, 12, and 18)
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores(Baseline and Week 8, 12, and 18)
Adverse events(Weekly from Weeks 1-18)
Change from baseline in electrocardiogram(Screening and Weeks 1, 8, 12, and 18)
Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale(Baseline and Weeks 1, 8, 12, and 18)
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores(Baseline and weekly from Weeks 1-18)
Change from baseline to endpoint in Patient Preference Scale (PPS) scores(Screening and Weeks 1, 8, 12, and 18)