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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.147 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

147

Conditions

Schizophrenia

Interventions

ClozapineDRUG

Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks

ZiprasidoneDRUG

Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Pfizer Investigational Site

Città di Castello, Perugia, Italy

Pfizer Investigational Site

Bassano del Grappa, Vicenza, Italy

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

Proportion of responders, based on change from baseline to endpoint in PANSS total score

Time frame: Until Final Visit (within 18 weeks)

Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores

Time frame: Baseline and weekly from Weeks 1-18

Time to discontinuation

Time frame: Up to 18 weeks

Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test

Time frame: Baseline and Weeks 12 and 18

Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores

Time frame: Baseline and Week 8, 12, and 18

Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores

Time frame: Baseline and Weeks 4, 8, 12, and 18

Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores

Time frame: Screening and Weeks 1, 8, 12, and 18

Change from baseline to endpoint in PANSS subscale scores

Time frame: Baseline and weekly from Weeks 1-18

Adverse events

Data from ClinicalTrials.gov

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