Psychotic Disorders, Schizophrenia
Conditions
Brief summary
The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline
Interventions
DRUGziprasidone
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria. * Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert
Exclusion criteria
* Resistance to conventional antipsychotic drugs * With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Improvement (CGI-I) | — |
| Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total | — |
| Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS) | — |
| Change from baseline in scores on the MADRS Without Items 4, 5 | — |
| Change from baseline in Global Assessment of Functioning (GAF) | — |
| Change From Baseline In Drug Attitude Inventory (DAI) | — |
| Change From Baseline In Clinical Global Impression Severity (CGI-S) | — |
| Change From Baseline In Prolactin And Lipid Levels | — |
| Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score | — |
| Change From Baseline in Barnes Akathisia Scale (BAS) | — |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score | — |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score | — |
| Change From Baseline In Weight | — |
Countries
Egypt, Greece, Jordan, Kuwait, Lebanon, Saudi Arabia, South Africa, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed