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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00681629 |
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: Quetiapine XR |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-Country, Multi-Centre Phase IV Study |
Enrollment: | 7 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Quetiapine XR
|
Drug: Quetiapine XR
400-800 mg, oral, bid
|
2: Experimental
Quetiapine XR combined with integrated care services
|
Drug: Quetiapine XR
Drug therapy and integrated care services
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Research Site | |
Stolberg, Germany | |
Research Site | |
Berlin, Germany | |
Research Site | |
Hamburg, Germany | |
Germany, Bayern | |
Research Site | |
Munchen, Bayern, Germany | |
Germany, Brandenburg | |
Research Site | |
Oranienburg, Brandenburg, Germany | |
Germany, Niedersachsen | |
Research Site | |
Luneburg, Niedersachsen, Germany | |
Research Site | |
Oldenburg, Niedersachsen, Germany | |
Germany, Sachsen | |
Research Site | |
Chemnitz, Sachsen, Germany |
Principal Investigator: | Martin Lambert, MD | Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany |
Responsible Party: | AstraZeneca, Germany ( Kai Richter MD, Medical Director (comm), MC Germany ) |
Study ID Numbers: | D1443L00048 |
Study First Received: | May 20, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00681629 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Schizophrenia Integrated Care Quetiapine |
Schizophrenia Quetiapine Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |