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)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649844
First received: March 28, 2008
Last updated: September 24, 2009
Last verified: September 2009

March 28, 2008
September 24, 2009
January 2003
Not Provided
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores [ Time Frame: Until Final Visit (within 18 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00649844 on ClinicalTrials.gov Archive Site
  • Proportion of responders, based on change from baseline to endpoint in PANSS total score [ Time Frame: Until Final Visit (within 18 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores [ Time Frame: Baseline and weekly from Weeks 1-18 ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores [ Time Frame: Baseline and Week 8, 12, and 18 ] [ Designated as safety issue: No ]
  • Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores [ Time Frame: Baseline and Weeks 4, 8, 12, and 18 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in PANSS subscale scores [ Time Frame: Baseline and weekly from Weeks 1-18 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weekly from Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores [ Time Frame: Baseline and Weeks 8, 12, and 18 ] [ Designated as safety issue: No ]
  • Change from baseline in Caregiver Activity Survey (CAS) [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ] [ Designated as safety issue: No ]
  • Change from baseline in laboratory tests [ Time Frame: Screening and weekly from Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Change from baseline in electrocardiogram [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores [ Time Frame: Baseline and weekly from Weeks 1-18 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Patient Preference Scale (PPS) scores [ Time Frame: Screening and Weeks 1, 8, 12, and 18 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Active Comparator: A
    Intervention: Drug: Clozapine
  • Experimental: B
    Intervention: Drug: Ziprasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
September 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00649844
A1281039
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

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