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OpenTrials
Completed

NCT Number: NCT00934726

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Primary outcomes

  1. Subject wellbeing under Neuroleptics scale (Quality of Life)

    Time frame: 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR

Acronym: PASQAL

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2009
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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