A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
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
1 other identifier
interventional
256
1 country
41
Brief Summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Apr 2004
Shorter than P25 for phase_4 schizophrenia
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedFebruary 21, 2021
February 1, 2021
March 5, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
28 days
Secondary Outcomes (16)
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
28 days
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
28 days
- +11 more secondary outcomes
Study Arms (2)
Aripiprazole
ACTIVE COMPARATORZiprasidone
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Psychiatric disorder other than schizophrenia or schizoaffective disorder
- History of arrhythmia, heart attack, or heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Pfizer Investigational Site
Anaheim, California, 92804, United States
Pfizer Investigational Site
Cerritos, California, 90703, United States
Pfizer Investigational Site
Culver City, California, 90232, United States
Pfizer Investigational Site
Garden Grove, California, 92845, United States
Pfizer Investigational Site
Glendale, California, 91206, United States
Pfizer Investigational Site
La Mesa, California, 91942, United States
Pfizer Investigational Site
Newport Beach, California, 92663, United States
Pfizer Investigational Site
Paramount, California, 90723, United States
Pfizer Investigational Site
Riverside, California, 92506, United States
Pfizer Investigational Site
San Diego, California, 92105, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
San Diego, California, 92126, United States
Pfizer Investigational Site
Torrance, California, 90505, United States
Pfizer Investigational Site
Upland, California, 91786, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016, United States
Pfizer Investigational Site
Hialeah, Florida, 33016, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71101, United States
Pfizer Investigational Site
Baltimore, Maryland, 21202, United States
Pfizer Investigational Site
Rockville, Maryland, 20850, United States
Pfizer Investigational Site
St Louis, Missouri, 63104, United States
Pfizer Investigational Site
St Louis, Missouri, 63118, United States
Pfizer Investigational Site
Clementon, New Jersey, 08021, United States
Pfizer Investigational Site
Princeton, New Jersey, 08540, United States
Pfizer Investigational Site
Willingboro, New Jersey, 08046, United States
Pfizer Investigational Site
Woodlane, New Jersey, 08060, United States
Pfizer Investigational Site
Jamaica, New York, 11418, United States
Pfizer Investigational Site
Staten Island, New York, 10305, United States
Pfizer Investigational Site
Butner, North Carolina, 27509, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7160, United States
Pfizer Investigational Site
Durham, North Carolina, 27705, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27603, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45220, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73118, United States
Pfizer Investigational Site
Bellaire, Texas, 77401, United States
Pfizer Investigational Site
Dallas, Texas, 75228, United States
Pfizer Investigational Site
Houston, Texas, 77008, United States
Pfizer Investigational Site
Irving, Texas, 75062, United States
Pfizer Investigational Site
Arlington, Virginia, 22204, United States
Pfizer Investigational Site
Arlington, Virginia, 22205, United States
Pfizer Investigational Site
Falls Church, Virginia, 22041, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
April 1, 2004
Study Completion
March 1, 2005
Last Updated
February 21, 2021
Record last verified: 2021-02