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

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ClinicalTrials.gov Identifier: NCT00934726
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : September 23, 2011
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease
Quality of Life in Schizophrenia

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR
Study Start Date : July 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Subject wellbeing under Neuroleptics scale (Quality of Life) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. BPRS (Brief Psychiatric Rating Scale) [ Time Frame: 4 months ]
  2. CGI (Clinical Global Impression) [ Time Frame: 4 months ]
  3. All adverse events occurring during the study will be documented [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The psychiatrists according to inclusion criteria select patients.

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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934726

Sponsors and Collaborators
Principal Investigator: Siegfried Kasper, Prof. AKH Vienna

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00934726     History of Changes
Other Study ID Numbers: NIS-NAT-SER-2008/1
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by AstraZeneca:
Quality of Life
Patient satisfaction
Investigate quality of life in schizophrenia

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders