Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms
Detailed description
The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.
Interventions
DRUGZiprasidone
Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients not currently being treated with antipsychotic medication and neuroleptic naive patients * Diagnosis of schizophrenia or schizoaffective disorder * Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years
Exclusion criteria
* Patients at immediate risk of committing harm to self or others * Treatment with clozapine within 3 months prior to baseline * History of neuroleptic treatment * Current antipsychotic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 | Week 24 |
| Change from baseline in PANSS (Depression-C) score at Week 24 | Week 24 |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 | Week 24 |
| Change from baseline in CGI-S total score at Week 24 | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Electrocardiogram | Screening and Month 4 |
| Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 | Week 24 |
| Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 | Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 |
| Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 | Week 24 |
Countries
Portugal
Outcome results
None listed