A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
- Registration Number
- NCT00634348
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aripiprazole Aripiprazole - Ziprasidone Ziprasidone -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. 28 days Change from baseline to endpoint in Patient Preference Scale (PPS) scores. 28 days Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. 28 days Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. 28 days Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. 28 days Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. 28 days Change from baseline to endpoint in Life Skills Profile (LSP). 28 days Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. 28 days Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores. 28 days Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. 28 days Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. 28 days Change from baseline to endpoint in Cognitive Battery. 28 days Change from baseline to Day 28 in movement disorder rating scale scores. 28 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Falls Church, Virginia, United States