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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634348
• Other study ID #: A1281110
• Status: Completed
• Phase: Phase 4
• Start date: April 2004
• Est. completion date: March 2005

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bellaire	Texas
United States	Pfizer Investigational Site	Butner	North Carolina
United States	Pfizer Investigational Site	Cerritos	California
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Culver City	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Falls Church	Virginia
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Hialeah	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Jamaica	New York
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Paramount	California
United States	Pfizer Investigational Site	Princeton	New Jersey
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Riverside	California
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Staten Island	New York
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Westampton	New Jersey
United States	Pfizer Investigational Site	Willingboro	New Jersey

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.		28 days
Primary	Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.		28 days
Secondary	Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.		28 days
Secondary	Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.		28 days
Secondary	Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.		28 days
Secondary	Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.		28 days
Secondary	Change from baseline to endpoint in Patient Preference Scale (PPS) scores.		28 days
Secondary	Change from baseline to endpoint in Life Skills Profile (LSP).		28 days
Secondary	Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.		28 days
Secondary	Change from baseline to endpoint in Cognitive Battery.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.		28 days
Secondary	Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.		28 days
Secondary	Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.		28 days
Secondary	Change from baseline to Day 28 in movement disorder rating scale scores.		28 days