Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics
Xperience
A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.
1 other identifier
observational
158
1 country
37
Brief Summary
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2008
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedOctober 27, 2010
October 1, 2010
1.8 years
May 29, 2008
October 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Eligibility Criteria
Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Alphen, Netherlands
Research Site
Amersfoort, Netherlands
Research Site
Amstelveen, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Arnhem, Netherlands
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Bennebroek, Netherlands
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Boxmeer, Netherlands
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Breda, Netherlands
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Doetinchem, Netherlands
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Echt, Netherlands
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Enkhuizen, Netherlands
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Enschede, Netherlands
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Haarlem, Netherlands
Research Site
Halsteren, Netherlands
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Helmond, Netherlands
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Heythuysen, Netherlands
Research Site
Hoorn, Netherlands
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Kerkrade, Netherlands
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Kloetinge, Netherlands
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Leeuwarden, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Oegstgeest, Netherlands
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Raalte, Netherlands
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Roermond, Netherlands
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Rotterdam, Netherlands
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Sluis, Netherlands
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Tiel, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Veenendaal, Netherlands
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Venray, Netherlands
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Vlaardingen, Netherlands
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Weert, Netherlands
Research Site
Zaandam, Netherlands
Research Site
Zoetermeer, Netherlands
Research Site
Zwolle, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 27, 2010
Record last verified: 2010-10