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)

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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Clozapine; Drug: Ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Italy
  • Bari, Italy, 70124
    • Pfizer Investigational Site
  • Brescia, Italy, 25100
    • Pfizer Investigational Site
  • Cagliari, Italy, 09045
    • Pfizer Investigational Site
  • Cagliari, Italy, 09124
    • Pfizer Investigational Site
  • Catania, Italy, 95123
    • Pfizer Investigational Site
  • Firenze, Italy, 50134
    • Pfizer Investigational Site
  • Guardiagrele (CH), Italy, 66016
    • Pfizer Investigational Site
  • Messina, Italy, 98100
    • Pfizer Investigational Site
  • Montichiari (brescia), Italy, 25018
    • Pfizer Investigational Site
  • Napoli, Italy, 80131
    • Pfizer Investigational Site
  • Parma, Italy, 43100
    • Pfizer Investigational Site
  • Reggio Calabria, Italy, 89100
    • Pfizer Investigational Site
  • Roma, Italy, 00135
    • Pfizer Investigational Site
  • Roma, Italy, 00137
    • Pfizer Investigational Site
  • Sassari, Italy, 07100
    • Pfizer Investigational Site
  • Siena, Italy, 53100
    • Pfizer Investigational Site
  • Torino, Italy, 10126
    • Pfizer Investigational Site
  • Trieste, Italy, 34126
    • Pfizer Investigational Site
  • Verona, Italy, 37126
    • Pfizer Investigational Site
  • Perugia
    • Citta' Di Castello, Perugia, Italy, 06012
      • Pfizer Investigational Site
  • Vicenza
    • Bassano Del Grappa, Vicenza, Italy, 36061
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Drug: Clozapine; 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
Experimental: B	Drug: Ziprasidone; 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; Other Names: Geodon, Zeldox

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of responders, based on change from baseline to endpoint in PANSS total score	Until Final Visit (within 18 weeks)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores	Baseline and weekly from Weeks 1-18
Time to discontinuation	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	Baseline and Weeks 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 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
Adverse events	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 Caregiver Activity Survey (CAS)	Screening and Weeks 1, 8, 12, and 18
Change from baseline in laboratory tests	Screening and 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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; GABA Agents; GABA Antagonists; Ziprasidone; Clozapine
• Other Study ID Numbers: A1281039