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

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92804
        • Pfizer Investigational Site
      • Cerritos, California, United States, 90703
        • Pfizer Investigational Site
      • Culver City, California, United States, 90232
        • Pfizer Investigational Site
      • Garden Grove, California, United States, 92845
        • Pfizer Investigational Site
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92663
        • Pfizer Investigational Site
      • Paramount, California, United States, 90723
        • Pfizer Investigational Site
      • Riverside, California, United States, 92506
        • Pfizer Investigational Site
      • San Diego, California, United States, 92105
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Diego, California, United States, 92126
        • Pfizer Investigational Site
      • Torrance, California, United States, 90505
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Pfizer Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20850
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63118
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Pfizer Investigational Site
      • Princeton, New Jersey, United States, 08540
        • Pfizer Investigational Site
      • Westampton, New Jersey, United States, 08060
        • Pfizer Investigational Site
      • Willingboro, New Jersey, United States, 08046
        • Pfizer Investigational Site
    • New York
      • Jamaica, New York, United States, 11418
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10305
        • Pfizer Investigational Site
    • North Carolina
      • Butner, North Carolina, United States, 27509
        • Pfizer Investigational Site
      • Chapel Hill, North Carolina, United States, 27599-7160
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27705
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27603
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45220
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pfizer Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75228
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77008
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75062
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Arlington, Virginia, United States, 22204
        • Pfizer Investigational Site
      • Falls Church, Virginia, United States, 22041
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Aripiprazole
Drug: 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
ACTIVE_COMPARATOR: Ziprasidone
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Time Frame: 28 days
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Time Frame: 28 days
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Time Frame: 28 days
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Life Skills Profile (LSP).
Time Frame: 28 days
28 days
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Time Frame: 28 days
28 days
Change from baseline to endpoint in Cognitive Battery.
Time Frame: 28 days
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Time Frame: 28 days
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Time Frame: 28 days
28 days
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Time Frame: 28 days
28 days
Change from baseline to Day 28 in movement disorder rating scale scores.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A1281110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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