Schizophrenia
Conditions
Brief summary
The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
Interventions
DRUGZiprasidone
Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
DRUGRisperidone
Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
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
* Diagnosis of schizophrenia * CGI-S score of 4 or less at baseline
Exclusion criteria
* Concurrent antipsychotic treatment * Treatment with antidepressants or mood stabilizers within 2 weeks of randomization * Acute exacerbation of schizophrenia within 3 months of baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 | Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24 | Day 1 and Weeks 4, 10, 12, 16, and 24 |
| Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24 | Day 1 and Weeks 1, 4, 12, 16, and 24 |
| Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24 | Day 1 and Weeks 1, 4, 12, 16, and 24 |
| Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24 | Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24 |
| Laboratory tests and electrocardiogram at Week 24 | Screening and Week 24 |
| Change from baseline in cognitive function assessment at Weeks 4 and 24 | Day 1 and Weeks 4 and 24 |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 | Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 |
| Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 | Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 |
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24 | Day 1 and Weeks 4, 10, 12, 16, and 24 |
| Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24 | Day 1 and Weeks 4, 10, 12, 16, and 24 |
| Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 | Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 |
Countries
Spain
Outcome results
None listed