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

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ClinicalTrials.gov Identifier: NCT00617214
Recruitment Status : Terminated (Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs)
First Posted : February 15, 2008
Last Update Posted : December 10, 2010
Sponsor:
Collaborator:
acromion GmbH
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease
Schizophrenia Schizoaffective Disorder Schizophreni-form Disorder Delusional Disorder Psychotic Disorder Not Otherwise Specified

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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


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

Secondary Outcome Measures :
  1. 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 ]
  2. Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI [ Time Frame: 6 month period of observation, 4 assesments ]
  3. Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss [ Time Frame: 6 month period of observation, 4 assesments ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617214


Locations
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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
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Study Director: Sandra Liedtke, MD AstraZeneca
Principal Investigator: Martin Lambert, PD, MD University of Hamberg
More Information
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ClinicalTrials.gov Identifier: NCT00617214    
Other Study ID Numbers: NIS-NDE-SER-2007/1
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: October 2008
Keywords provided by AstraZeneca:
Schizophrenia
Integrated care program
Seroquel
Additional relevant MeSH terms:
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Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
 Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders