Schizophrenic Patients in Integrated Care - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681629

Purpose

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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Proportion of patients with SWN-K>=80 after 18 month [ Time Frame: 6 times during course of the study incl. baseline and final visit after 18month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in efficacy scales CGI-S, PANSS-8 [ Time Frame: 6 times during course of the study incl. baseline and final visit after 18month ] [ Designated as safety issue: No ]
Change in functional outcome (GAF, PSP, EQ-5D, Q-LES-Q18) [ Time Frame: 6 times during course of the study incl. baseline and final visit after 18month ] [ Designated as safety issue: No ]
Change in compliance and effect on health economy aspects [ Time Frame: 6 times during course of the study incl. baseline and final visit after 18month ] [ Designated as safety issue: No ]

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

Eligibility

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

Criteria

Inclusion Criteria:

Patients with baseline SWN-K <=70
Provision of signed informed consent
Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
Patients who pose an imminent risk of suicide or danger to self or others

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681629

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Martin Lambert, MD

Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany

More Information

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

Keywords provided by AstraZeneca:

Schizophrenia
Integrated Care
Quetiapine

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 13, 2009