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:
AstraZeneca
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
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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
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:
|
Schizophrenia, Paranoid Delusions Psychotic Disorders Mental Disorders |
Schizophrenia Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013