drugset / Trial / NCT00600756
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K
Timeline
- Start
- 2008-01
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quetiapine | Small molecule | 400 mg | Oral |
| Subject | Quetiapine | Small molecule | 800 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 2 mg | Oral |
| Comparator | Risperidone | Other / unclassified | 6 mg | Oral |