NCT00600756

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

A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 798 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Schizophrenic Disorders

Interventions

Type	Name	Description
DRUG	Quetiapine XR	Oral, once daily, tablets of 400 mg to 800 mg
DRUG	Risperidone	Oral, once daily, tablets of 2 mg to 6 mg

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-01-25
• Last updated: 2012-10-05
• Results posted: 2012-09-12

Locations

116 sites across 14 countries: Belgium, Brazil, Bulgaria, Costa Rica, Finland, Germany, Italy, Mexico, Portugal, Romania, Russia, Spain, Switzerland, Turkey (Türkiye)