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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Clozapine
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 147
Study Start Date: January 2003
Study Completion Date: September 2004
Arms Assigned Interventions
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 Name: Geodon, Zeldox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649844

Locations
Italy
Pfizer Investigational Site
Citta' Di Castello, Perugia, Italy, 06012
Pfizer Investigational Site
Bassano Del Grappa, Vicenza, Italy, 36061
Pfizer Investigational Site
Bari, Italy, 70124
Pfizer Investigational Site
Brescia, Italy, 25100
Pfizer Investigational Site
Cagliari, Italy, 09124
Pfizer Investigational Site
Cagliari, Italy, 09045
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, 00137
Pfizer Investigational Site
Roma, Italy, 00135
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
Unknown, Italy, 00100
Pfizer Investigational Site
Unknown, Italy
Pfizer Investigational Site
Verona, Italy, 37126
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649844     History of Changes
Other Study ID Numbers: A1281039
Study First Received: March 28, 2008
Last Updated: September 24, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Ziprasidone
Clozapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on October 01, 2014