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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00255515 |
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Quetiapine fumarate Drug: conventional treatment for schizophrenia |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia. |
Enrollment: | 85 |
Study Start Date: | September 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
quetiapine fumarate
|
Drug: Quetiapine fumarate
oral
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2: Active Comparator
Conventional treatment for schizophrenia
|
Drug: conventional treatment for schizophrenia
various standard therapies
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3: Experimental
quetiapine fumarate + Cognitive Remediation Therapy
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Drug: Quetiapine fumarate
oral
|
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Research Site | |
ESKILSTUNA, Sweden | |
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GÖTEBORG, Sweden | |
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HUDDINGE, Sweden | |
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JÖNKÖPING, Sweden | |
Research Site | |
LIMHAMN, Sweden | |
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LUND, Sweden | |
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MALMÖ, Sweden | |
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Hisingsbacka, Sweden | |
Research Site | |
STOCKHOLM, Sweden | |
Research Site | |
Umeå, Sweden | |
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Vasteras, Sweden | |
Research Site | |
Lidingö, Sweden | |
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Nyköping, Sweden | |
Research Site | |
Trollhättan, Sweden | |
Research Site | |
NORSBORG, Sweden |
Principal Investigator: | Leif Lindström, | Västerås |
Responsible Party: | AstraZeneca Sweden ( Birgit Ekholm, MD, Neuroscience ) |
Study ID Numbers: | D1449L00004, SCORE |
Study First Received: | November 17, 2005 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00255515 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Central Nervous System Depressants Psychotic Disorders Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |