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

NCT00600756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 798

Last updated 2012-10-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Martin Brecher, MSD · AstraZeneca

  • Prof Naber, MD · Klinikum Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Belgium
  • Brazil
  • Bulgaria
  • Costa Rica
  • Finland
  • Germany
  • Italy
  • Mexico
  • Portugal
  • Romania
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600756 on ClinicalTrials.gov