A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Clozapine; Drug: Ziprasidone

• Registration Number: NCT00649844
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-09
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Clozapine	-
B	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores	Until Final Visit (within 18 weeks)

Secondary Outcome Measures

Name	Time	Method
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
Adverse events	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
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

Trial Locations

Locations (1)

Pfizer Investigational Site