Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00689325
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Diagnosis of schizophrenia
• Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.
• Patient takes an AAP according to local SPC and current medical practice
• The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write

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Exclusion Criteria

• Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study
• Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.
• Previous enrolment or treatment in the present NIS
• Known allergy to the prescribed AAP or any of its substances

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.	At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation

Secondary Outcome Measures

Name	Time	Method
Positive And Negative Syndrome Scale-PANSS-8score	At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Global Assessment of Functioning 'GAF' scale	At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Disease insight; G-12 item of PANSS	At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation

Trial Locations

Locations (1)

Research Site; 🇳🇱 Zwolle, Netherlands