A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

NCT ID: NCT00645515

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-12-31

Brief Summary

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The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Arm B

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Interventions

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Ziprasidone

Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Intervention Type DRUG

Risperidone

Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Intervention Type DRUG

Other Intervention Names

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Geodon, Zeldox

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia
* CGI-S score of 4 or less at baseline

Exclusion Criteria

* Concurrent antipsychotic treatment
* Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
* Acute exacerbation of schizophrenia within 3 months of baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bilbao, Vizcaya, Spain

Site Status

Pfizer Investigational Site

Getxo, Vizcaya, Spain

Site Status

Pfizer Investigational Site

Madrid, , Spain

Site Status

Countries

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Spain

Related Links

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Other Identifiers

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A1281065

Identifier Type: -

Identifier Source: org_study_id

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