CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 798 enrolled
Drug / intervention
Quetiapine XR +1 moredrug
Likely dose
Quetiapine XR 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00600756
NCT00600756Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jan 25, 2008·Updated Oct 5, 2012

In Brief

A Phase 3 clinical trial evaluating Quetiapine XR and Risperidone for Schizophrenic Disorders. Completed, enrolled 798 participants across 116 sites in 14 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenic Disorders
CountriesBelgium, Brazil, Bulgaria, Costa Rica, Finland, Germany, Italy, Mexico, Portugal, Romania, Russia, Spain, Switzerland, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2008
Enrollment StartJan 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

Quetiapine XRdrug

Oral, once daily, tablets of 400 mg to 800 mg

Risperidonedrug

Oral, once daily, tablets of 2 mg to 6 mg