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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)
Sponsor:
Collaborator:
acromion GmbH
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00617214
First received: February 5, 2008
Last updated: December 8, 2010
Last verified: October 2008
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov Identifier: NCT00617214     History of Changes
Other Study ID Numbers: NIS-NDE-SER-2007/1
Study First Received: February 5, 2008
Last Updated: December 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Schizophrenia
Integrated care program
Seroquel

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014