Trial intelligence / Profile preview

Ziprasidone vs Clozapine in Refractory Schizophrenia

NCT00649844Phase 3

Key facts

Status: Completed
Start: Jan 2003
Countries: 1
Sponsor: Viatris
Modality: Small Molecules

Drugs: ziprasidone
Conditions: schizophrenia

Overview

Phase 3, randomised, double-blind trial of ziprasidone in schizophrenia (2 arms), sponsored by Viatris. Primary endpoint: Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores at 18 weeks. Started Jan 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Clozapine
Clozapine 25-600 mg/day
Ziprasidone
Ziprasidone 40-160 mg/day

Who it enrols

Patients with schizophrenia who are refractory and/or intolerant to antipsychotic therapy, with CGI-S >= 4 and PANSS >= 80.

Endpoints

Primary

Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores18 weeks

Secondary

Proportion of responders based on PANSS total score18 weeks
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores18 weeks
Time to discontinuation18 weeks
Change from baseline to endpoint in cognitive function assessments18 weeks
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores18 weeks
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores18 weeks
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores18 weeks
Change from baseline to endpoint in PANSS subscale scores18 weeks

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