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

Sponsored by:	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 III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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.

Estimated Enrollment:	732
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Quetiapine XR
2: Active Comparator	Drug: Risperidone

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

Study ID Numbers:	D1443L00039
Study First Received:	January 9, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00600756
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

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Dopamine
Mental Disorders

Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009