drugset / Trial / NCT00946985
28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
RandomizedParallel-groupOpen-labelPrevention
Summary
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
Timeline
- Start
- 2009-06
- Primary completion
- 2010-03
- Completion
- 2010-03
Outcome
Outcome not reported
Stopped (Enrollment): “The recruitment rate for the study was inadequate to achieve its enrollment goals.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Risperidone | Other / unclassified | 2 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 4 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 6 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 8 mg | Oral |
| Subject | paliperidone palmitate | Unknown | 50 mg | Other |
| Subject | paliperidone palmitate | Unknown | 75 mg | Other |
| Subject | paliperidone palmitate | Unknown | 100 mg | Other |
| Subject | paliperidone palmitate | Unknown | 150 mg | Other |