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

Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life in Schizophrenia

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The psychiatrists according to inclusion criteria select patients.

Description

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…)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1 group, schizophrenia patients; Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject wellbeing under Neuroleptics scale (Quality of Life)	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
BPRS (Brief Psychiatric Rating Scale)	4 months
CGI (Clinical Global Impression)	4 months
All adverse events occurring during the study will be documented	4 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Siegfried Kasper, Prof., AKH Vienna

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): September 23, 2011
• Last Update Submitted That Met QC Criteria: September 22, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Schizophrenia; Patient satisfaction; Quality of Life; Investigate quality of life in schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: NIS-NAT-SER-2008/1