A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

NCT ID: NCT00634348

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-03-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

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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Aripiprazole

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days

Ziprasidone

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days

Interventions

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Aripiprazole

Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days

Intervention Type DRUG

Ziprasidone

Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients with schizophrenia or schizoaffective disorder
* At least a 6th grade reading level
* Males or females, between 18 and 70 years of age at the time of consent
* Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening

Exclusion Criteria

* Psychiatric disorder other than schizophrenia or schizoaffective disorder
* History of arrhythmia, heart attack, or heart failure
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

Anaheim, California, United States

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Cerritos, California, United States

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Culver City, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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La Mesa, California, United States

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Newport Beach, California, United States

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Paramount, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Upland, California, United States

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Washington D.C., District of Columbia, United States

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Hialeah, Florida, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Clementon, New Jersey, United States

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Princeton, New Jersey, United States

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Willingboro, New Jersey, United States

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Woodlane, New Jersey, United States

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Jamaica, New York, United States

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Staten Island, New York, United States

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Butner, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Arlington, Virginia, United States

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Arlington, Virginia, United States

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Falls Church, Virginia, United States

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Countries

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United States

Other Identifiers

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A1281110

Identifier Type: -

Identifier Source: org_study_id

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