Non-interventional Open Label Study to Investigate the Effect of Quetiapine XR on Patient Satisfaction and Quality of Life in Patients With Schizophrenia

NCT ID: NCT00934726

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-10-31

Brief Summary

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Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.

Detailed Description

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Conditions

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Quality of Life in Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 group, schizophrenia patients

Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult schizophrenia patients
* Inclusion according to Summary of product characteristics

Exclusion Criteria

* Diagnosis other than schizophrenia
* Patients for which Seroquel XR is not registered (pregnant women, children and adolescents…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siegfried Kasper, Prof.

Role: PRINCIPAL_INVESTIGATOR

AKH Vienna

Other Identifiers

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NIS-NAT-SER-2008/1

Identifier Type: -

Identifier Source: org_study_id