Schizophrenia
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment
Interventions
DRUGClozapine
Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks
DRUGZiprasidone
Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 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 No maximum
Healthy volunteers
No
Inclusion criteria
* CGI - S ≥4 * PANSS ≥ 80 * Inpatients or outpatients
Exclusion criteria
* Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug * Diagnosis of substance dependence within previous 3 months using DSM-IV criteria * History of seizure * Organic mental disease, including mental retardation or epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores | Until Final Visit (within 18 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores | Baseline and weekly from Weeks 1-18 |
| Time to discontinuation | Up to 18 weeks |
| Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test | Baseline and Weeks 12 and 18 |
| Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores | Baseline and Week 8, 12, and 18 |
| Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores | Baseline and Weeks 4, 8, 12, and 18 |
| Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline to endpoint in PANSS subscale scores | Baseline and weekly from Weeks 1-18 |
| Proportion of responders, based on change from baseline to endpoint in PANSS total score | Until Final Visit (within 18 weeks) |
| Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores | Baseline and Weeks 8, 12, and 18 |
| Change from baseline in Caregiver Activity Survey (CAS) | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline in laboratory tests | Screening and weekly from Weeks 1-18 |
| Change from baseline in electrocardiogram | Screening and Weeks 1, 8, 12, and 18 |
| Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale | Baseline and Weeks 1, 8, 12, and 18 |
| Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores | Baseline and weekly from Weeks 1-18 |
| Change from baseline to endpoint in Patient Preference Scale (PPS) scores | Screening and Weeks 1, 8, 12, and 18 |
| Adverse events | Weekly from Weeks 1-18 |
Countries
Italy
Outcome results
None listed