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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
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
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Time frame: 28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Time frame: 28 days
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
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Time frame: 28 days
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Time frame: 28 days
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Time frame: 28 days
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Time frame: 28 days
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Time frame: 28 days
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Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Cerritos, California, United States
Pfizer Investigational Site
Culver City, California, United States
Pfizer Investigational Site
Garden Grove, California, United States
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
La Mesa, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Riverside, California, United States
Pfizer Investigational Site
San Diego, California, United States
...and 31 more locations
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Time frame: 28 days
Change from baseline to endpoint in Life Skills Profile (LSP).
Time frame: 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
Change from baseline to endpoint in Cognitive Battery.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Time frame: 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
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Time frame: 28 days
Change from baseline to Day 28 in movement disorder rating scale scores.
Time frame: 28 days