Schizophrenic Patients Taking Part in Integrated Care Program - Full Text View

Schizophrenic Patients Taking Part in Integrated Care Program (CARE I)

This study has been terminated.

( Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs )

First Received: February 5, 2008 Last Updated: October 30, 2008 History of Changes

Sponsors and Collaborators:	AstraZeneca acromion GmbH
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00617214

Purpose

Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.

Condition
Schizophrenia Schizoaffective Disorder Schizophreni-Form Disorder Delusional Disorder Psychotic Disorder Not Otherwise Specified

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-Country, Multi-Centre Non-Interventional Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Subjective Well-Being measured via SWN patient questionnaire [ Time Frame: 6 month period of observation,4 assessments ]

Secondary Outcome Measures:

Quality of Life and patient`s satisfaction measured by Q-LES-Q-18 and CSQ-8 [ Time Frame: 6 month period of observation, 1 assessment at end of NIS ]
Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI [ Time Frame: 6 month period of observation, 4 assesments ]
Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss [ Time Frame: 6 month period of observation, 4 assesments ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	20
Study Start Date:	January 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
All Schizophrenic outpatients who are treated with Seroquel IR and who are additionally intended to start with an integrated care program

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

outpatient department from clinics or private practices

Criteria

Inclusion Criteria:

Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
Age 18 - 65 years
Current stable treatment with Seroquel according to SmPC since at least 2 months
Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS

Exclusion Criteria:

Presence of any contraindication as described in the SmPC
Cancellation of participation in the integrated care program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617214

Locations

Germany
Research Site
Hamburg, Germany
Research Site
Oldenburg, Germany
Research Site
Berlin, Germany
Research Site
Spremberg, Germany
Research Site
Mittweida, Germany
Research Site
Zittau, Germany
Research Site
Munster, Germany
Research Site
Munchen, Germany
Research Site
Bonn, Germany
Research Site
Ahrweiler, Germany
Research Site
Mannheim, Germany
Research Site
Werneck, Germany
Research Site
Munchen, Germany
Research Site
Ottobrunn, Germany
Research Site
Stolberg, Germany

Sponsors and Collaborators

AstraZeneca

acromion GmbH

Investigators

Study Director:	Sandra Liedtke, MD	AstraZeneca
Principal Investigator:	Martin Lambert, PD, MD	University of Hamberg

More Information

No publications provided

Study ID Numbers:	NIS-NDE-SER-2007/1
Study First Received:	February 5, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00617214 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Schizophrenia
Integrated care program
Seroquel

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Schizophrenia, Paranoid
Delusions

Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia, Paranoid
Pathologic Processes
Disease

Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009