drugset / Trial / NCT00600756

Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone

NCT00600756

Phase 3 Completed 798 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
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

Indications