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

December 8, 2010 updated by: AstraZeneca

Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

outpatient department from clinics or private practices

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
6 month period of observation, 4 assesments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

acromion GmbH

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NDE-SER-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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