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Completed

NCT Number: NCT00649844

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Città di Castello, Perugia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clozapine

Drug

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

Ziprasidone

Drug

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

Primary outcomes

  1. Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores

    Time frame: Until Final Visit (within 18 weeks)

Secondary outcomes

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

    Time frame: Until Final Visit (within 18 weeks)

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

    Time frame: Baseline and weekly from Weeks 1-18

  3. Time to discontinuation

    Time frame: Up to 18 weeks

  4. 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

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

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

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

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

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

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

  8. Change from baseline to endpoint in PANSS subscale scores

    Time frame: Baseline and weekly from Weeks 1-18

  9. Adverse events

    Time frame: Weekly from Weeks 1-18

  10. Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores

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

  11. Change from baseline in Caregiver Activity Survey (CAS)

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

  12. Change from baseline in laboratory tests

    Time frame: Screening and weekly from Weeks 1-18

  13. Change from baseline in electrocardiogram

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

  14. Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale

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

  15. Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores

    Time frame: Baseline and weekly from Weeks 1-18

  16. Change from baseline to endpoint in Patient Preference Scale (PPS) scores

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: MOZART

Important dates

Study start
2003
Study completion
2004
First posted
Apr 1, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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