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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00600756 |
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 |
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 |
Estimated Enrollment: | 732 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | October 2009 |
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 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Martin Brecher, MSD | AstraZeneca |
Principal Investigator: | Prof Naber, MD | Klinikum Eppendorf |
Study ID Numbers: | D1443L00039 |
Study First Received: | January 9, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00600756 History of Changes |
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 |
schizophrenia SWNK |
Neurotransmitter Agents Tranquilizing Agents Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Schizophrenia Quetiapine Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Quetiapine Serotonin Antagonists Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |