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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00934726
First received: July 7, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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
Quality of Life in Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Subject wellbeing under Neuroleptics scale (Quality of Life) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BPRS (Brief Psychiatric Rating Scale) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • CGI (Clinical Global Impression) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • All adverse events occurring during the study will be documented [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 group, schizophrenia patients
Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The psychiatrists according to inclusion criteria select patients.

Criteria

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…)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934726

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Siegfried Kasper, Prof. AKH Vienna
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00934726     History of Changes
Other Study ID Numbers: NIS-NAT-SER-2008/1
Study First Received: July 7, 2009
Last Updated: September 22, 2011
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014