Schizophrenia
Conditions
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
Interventions
DRUGAripiprazole
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
DRUGZiprasidone
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
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 Personal Evaluation of Transition in Treatment (PETiT) scale scores. | 28 days |
| Change from baseline to endpoint in Patient Preference Scale (PPS) scores. | 28 days |
| 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 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 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 to Day 28 in movement disorder rating scale 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 negative subscale scores. | 28 days |
Countries
United States
Outcome results
None listed