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NCT00617214 Clinical Trial

Schizophrenic Patients Taking Part in Integrated Care Program

Schizophrenia Clinical Trial

— CARE I  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00617214
Other study ID # NIS-NDE-SER-2007/1
Secondary ID
Status Terminated
Phase N/A
First received February 5, 2008
Last updated December 8, 2010
Start date January 2008
Est. completion date December 2008

Study information
Verified date October 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca acromion GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective Well-Being measured via SWN patient questionnaire 6 month period of observation,4 assessments
Secondary Quality of Life and patient`s satisfaction measured by Q-LES-Q-18 and CSQ-8 6 month period of observation, 1 assessment at end of NIS
Secondary Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI 6 month period of observation, 4 assesments
Secondary Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss 6 month period of observation, 4 assesments
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