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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)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clozapine
Ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of responders, based on change from baseline to endpoint in PANSS total score
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
Time to discontinuation
Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores
Change from baseline to endpoint in PANSS subscale scores
Adverse events
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores
Change from baseline in Caregiver Activity Survey (CAS)
Change from baseline in laboratory tests
Change from baseline in electrocardiogram
Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores
Change from baseline to endpoint in Patient Preference Scale (PPS) scores

Full Information

First Posted
March 28, 2008
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00649844
Brief Title
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
Acronym
MOZART
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clozapine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
Time Frame
Until Final Visit (within 18 weeks)
Secondary Outcome Measure Information:
Title
Proportion of responders, based on change from baseline to endpoint in PANSS total score
Time Frame
Until Final Visit (within 18 weeks)
Title
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
Time Frame
Baseline and weekly from Weeks 1-18
Title
Time to discontinuation
Time Frame
Up to 18 weeks
Title
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
Title
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores
Time Frame
Baseline and Week 8, 12, and 18
Title
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores
Time Frame
Baseline and Weeks 4, 8, 12, and 18
Title
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores
Time Frame
Screening and Weeks 1, 8, 12, and 18
Title
Change from baseline to endpoint in PANSS subscale scores
Time Frame
Baseline and weekly from Weeks 1-18
Title
Adverse events
Time Frame
Weekly from Weeks 1-18
Title
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores
Time Frame
Baseline and Weeks 8, 12, and 18
Title
Change from baseline in Caregiver Activity Survey (CAS)
Time Frame
Screening and Weeks 1, 8, 12, and 18
Title
Change from baseline in laboratory tests
Time Frame
Screening and weekly from Weeks 1-18
Title
Change from baseline in electrocardiogram
Time Frame
Screening and Weeks 1, 8, 12, and 18
Title
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
Title
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores
Time Frame
Baseline and weekly from Weeks 1-18
Title
Change from baseline to endpoint in Patient Preference Scale (PPS) scores
Time Frame
Screening and Weeks 1, 8, 12, and 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Citta' Di Castello
State/Province
Perugia
ZIP/Postal Code
06012
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bassano Del Grappa
State/Province
Vicenza
ZIP/Postal Code
36061
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cagliari
ZIP/Postal Code
09045
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Pfizer Investigational Site
City
Guardiagrele (CH)
ZIP/Postal Code
66016
Country
Italy
Facility Name
Pfizer Investigational Site
City
Messina
ZIP/Postal Code
98100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Montichiari (brescia)
ZIP/Postal Code
25018
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00137
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Trieste
ZIP/Postal Code
34126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281039&StudyName=A%20study%20comparing%20the%20efficacy%20and%20tolerability%20of%20ziprasidone%20vs.%20clozapine%20for%20the%20treatment%20of%20schizophrenia%20in%20patients%20who%20continue
Description
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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

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