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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00600756

Purpose

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

Condition	Intervention	Phase
Schizophrenic Disorders	Drug: Quetiapine XR Drug: Risperidone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: 1 year ]

Secondary Outcome Measures:

Among other things a secondary objective of particular interest is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 12 by evaluating the change from baseline in SWN-K mean total score.

Enrollment:	798
Study Start Date:	January 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Quetiapine XR Other Name: Seroquel XR
Active Comparator: 2	Drug: Risperidone Other Name: Risperdal

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Exclusion Criteria:

Patients with a baseline SWN-K total score of >75
Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600756

Show 116 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Martin Brecher, MSD	AstraZeneca
Principal Investigator:	Prof Naber, MD	Klinikum Eppendorf

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00600756 History of Changes
Other Study ID Numbers:	D1443L00039
Study First Received:	January 9, 2008
Last Updated:	February 22, 2010
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Brazil: Ministry of Health Bulgaria: Ministry of Health Costa Rica: Ministry of Health Costa Rica Denmark: The Ministry of the Interior and Health Finland: Ministry of Social Affairs and Health Germany: Federal Institute for Drugs and Medical Devices Italy: National Institute of Health Mexico: National Institute of Public Health, Health Secretariat Portugal: National Pharmacy and Medicines Institute Romania: Ministry of Public Health Russia: Ministry of Health and Social Development of the Russian Federation Spain: Ministry of Health and Consumption Switzerland: Federal Office of Public Health Turkey: Ministry of Health

Keywords provided by AstraZeneca:

schizophrenia
SWNK

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 24, 2012