MOZART: 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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00649844

Collaborator

(none)

147

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Clozapine Drug: Ziprasidone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jan 1, 2003

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Geodon, Zeldox

Arm

Intervention/Treatment

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 Names:

Geodon, Zeldox

Outcome Measures

Primary Outcome Measures

Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores [Until Final Visit (within 18 weeks)]

Secondary Outcome Measures

Proportion of responders, based on change from baseline to endpoint in PANSS total score [Until Final Visit (within 18 weeks)]
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores [Baseline and weekly from Weeks 1-18]
Time to discontinuation [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 [Baseline and Weeks 12 and 18]
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores [Baseline and Week 8, 12, and 18]
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores [Baseline and Weeks 4, 8, 12, and 18]
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores [Screening and Weeks 1, 8, 12, and 18]
Change from baseline to endpoint in PANSS subscale scores [Baseline and weekly from Weeks 1-18]
Adverse events [Weekly from Weeks 1-18]
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores [Baseline and Weeks 8, 12, and 18]
Change from baseline in Caregiver Activity Survey (CAS) [Screening and Weeks 1, 8, 12, and 18]
Change from baseline in laboratory tests [Screening and weekly from Weeks 1-18]
Change from baseline in electrocardiogram [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 [Baseline and Weeks 1, 8, 12, and 18]
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores [Baseline and weekly from Weeks 1-18]
Change from baseline to endpoint in Patient Preference Scale (PPS) scores [Screening and Weeks 1, 8, 12, and 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Citta' Di Castello	Perugia	Italy	06012
2	Pfizer Investigational Site	Bassano Del Grappa	Vicenza	Italy	36061
3	Pfizer Investigational Site	Bari		Italy	70124
4	Pfizer Investigational Site	Brescia		Italy	25100
5	Pfizer Investigational Site	Cagliari		Italy	09045
6	Pfizer Investigational Site	Cagliari		Italy	09124
7	Pfizer Investigational Site	Catania		Italy	95123
8	Pfizer Investigational Site	Firenze		Italy	50134
9	Pfizer Investigational Site	Guardiagrele (CH)		Italy	66016
10	Pfizer Investigational Site	Messina		Italy	98100
11	Pfizer Investigational Site	Montichiari (brescia)		Italy	25018
12	Pfizer Investigational Site	Napoli		Italy	80131
13	Pfizer Investigational Site	Parma		Italy	43100
14	Pfizer Investigational Site	Reggio Calabria		Italy	89100
15	Pfizer Investigational Site	Roma		Italy	00135
16	Pfizer Investigational Site	Roma		Italy	00137
17	Pfizer Investigational Site	Sassari		Italy	07100
18	Pfizer Investigational Site	Siena		Italy	53100
19	Pfizer Investigational Site	Torino		Italy	10126
20	Pfizer Investigational Site	Trieste		Italy	34126
21	Pfizer Investigational Site	Verona		Italy	37126
22	Pfizer Investigational Site

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT00649844

Other Study ID Numbers:

A1281039

First Posted:

Apr 1, 2008

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Schizophrenia

Ziprasidone

Clozapine

Study Results

No Results Posted as of Feb 21, 2021