Clinical trial NCT00617214: Schizophrenic Patients Taking Part in Integrated Care Program
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreni-form Disorder
Delusional Disorder
Psychotic Disorder Not Otherwise Specified
Keywords: Schizophrenia
Integrated care program
Seroquel
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: acromion GmbH
First posted: 2008-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatient department from clinics or private practices

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.


Eligibility 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

Primary outcomes:
measure: Subjective Well-Being measured via SWN patient questionnaire
timeFrame: 6 month period of observation,4 assessments
Secondary outcomes:
measure: Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8
timeFrame: 6 month period of observation, 1 assessment at end of NIS
measure: Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI
timeFrame: 6 month period of observation, 4 assesments
measure: Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss
timeFrame: 6 month period of observation, 4 assesments
Other outcomes:
Locations:
city: Ahrweiler
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Mittweida
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Ottobrunn
country: Germany
facility: Research Site
city: Spremberg
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
city: Werneck
country: Germany
facility: Research Site
city: Zittau
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Sandra Liedtke, MD
role: STUDY_DIRECTOR
affiliation: University of Hamberg
name: Martin Lambert, PD, MD
role: PRINCIPAL_INVESTIGATOR
References: