Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics (Xperience)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689325
First received: May 29, 2008
Last updated: October 26, 2010
Last verified: October 2010
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Purpose
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.
| Condition |
|---|
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Schizophrenia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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. [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Positive And Negative Syndrome Scale-PANSS-8score [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
- Global Assessment of Functioning 'GAF' scale [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
- Disease insight; G-12 item of PANSS [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 158 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission
Criteria
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689325
Locations
| Netherlands | |
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| Alphen, Netherlands | |
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| Amersfoort, Netherlands | |
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| Amstelveen, Netherlands | |
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| Amsterdam, Netherlands | |
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| 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 | |
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| Halsteren, Netherlands | |
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| Helmond, Netherlands | |
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| Heythuizen, Netherlands | |
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| 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 | |
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| Zaandam, Netherlands | |
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| Zoetermeer, Netherlands | |
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| Zwolle, Netherlands | |
Sponsors and Collaborators
AstraZeneca
More Information
No publications provided
| Responsible Party: | Hans Eriksson, Medical Science Sr Director, AstraZeneca, Medical Science, Wilmington USA |
| ClinicalTrials.gov Identifier: | NCT00689325 History of Changes |
| Other Study ID Numbers: | NIS-NNL-SER-2008/1 |
| Study First Received: | May 29, 2008 |
| Last Updated: | October 26, 2010 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by AstraZeneca:
|
Schizophrenia remission subjective well-being and effectiveness Quality of Life |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013