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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00833456 |
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Date of registration:
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29/01/2009 |
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Primary sponsor: |
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Public title:
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NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia
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Scientific title:
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Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00833456 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Peter Pregelj, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
- patients' symptoms are controlled with Seroquel SR started up to 1 month before the
inclusion
- or patients' symptoms are controlled with other atypical antipsychotic in once daily
formulation started up to 1 month before the inclusion
Exclusion Criteria:
- patients who are treated with Seroquel SR or other antipsychotic more than 1 month
- patients with prescribed antipsychotic combinations
- pregnant women or women who are breast-feeding
- patients who have been treated with antipsychotics in depot formulations for the last
two months
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Primary Outcome(s)
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To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.
[Time Frame: three times: 0, 12 and 24 weeks after inclusion]
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Secondary Outcome(s)
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To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics
[Time Frame: three times: 0, 12 and 24 weeks after inclusion]
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Secondary ID(s)
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NIS-NSI-SER-2008/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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