Schizophrenia Clinical Trial
— UPTAQEOfficial title:
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Verified date | April 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Not required for this study: |
Study type | Observational |
With this observational study we want to examine if the intensity of agitation, the
intensity of psychotic symptoms and the presence of sleeping disorder predict the success of
the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a
psychotic and/or manic episode. In this study it will be examined what the percentage of
patients with a 2-point improvement at the CGI-scale is. Of these group, the responders,
retrospective the profile of the responders will be analysed (key-factors and confounders).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
was changed to XR after consultation with FDA.
Status | Completed |
Enrollment | 387 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode) - Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone - Patients who are prepared to consent to make the coded data available to AstraZeneca - Patients with a CGI = 4 Exclusion Criteria: - Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike). - Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products - Patients unable to give informed consent according to the attending physician |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Research Site | Alkmaar | |
Netherlands | Research Site | Almelo | |
Netherlands | Research Site | Alphen aan de Rigjn | |
Netherlands | Research Site | Amersfoort | |
Netherlands | Research Site | Amstelveen | |
Netherlands | Research Site | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Netherlands,
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