Schizophrenic Patients Taking Part in Integrated Care Program

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreni-form Disorder; Delusional Disorder; Psychotic Disorder Not Otherwise Specified

• Registration Number: NCT00617214
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Status Verified: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective Well-Being measured via SWN patient questionnaire	6 month period of observation,4 assessments

Secondary Outcome Measures

Name	Time	Method
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
Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI	6 month period of observation, 4 assesments
Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss	6 month period of observation, 4 assesments

Trial Locations

Locations (1)

Research Site; 🇩🇪 Zittau, Germany