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Trial record 1 of 1 for:    NCT00649844
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00649844
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : September 25, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date September 25, 2009
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores [ Time Frame: Until Final Visit (within 18 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
  • 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 [ Time Frame: Weekly from Weeks 1-18 ]
  • Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores [ Time Frame: Baseline and Weeks 8, 12, and 18 ]
  • Change from baseline in Caregiver Activity Survey (CAS) [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ]
  • Change from baseline in laboratory tests [ Time Frame: Screening and weekly from Weeks 1-18 ]
  • Change from baseline in electrocardiogram [ Time Frame: 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 [ Time Frame: Baseline and Weeks 1, 8, 12, and 18 ]
  • Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores [ Time Frame: Baseline and weekly from Weeks 1-18 ]
  • Change from baseline to endpoint in Patient Preference Scale (PPS) scores [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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 Name: Geodon, Zeldox
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Clozapine
  • Experimental: B
    Intervention: Drug: Ziprasidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)
147
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649844
Other Study ID Numbers  ICMJE A1281039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP