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 (MOZART)

Viatris

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Ziprasidone; Drug: Clozapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649844

A1281039

Details and patient eligibility

About

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

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Clozapine

B

Experimental group

Treatment:

Drug: Ziprasidone