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Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

Completed
Conditions
Mania
Schizophrenia
Registration Number
NCT00534222
Lead Sponsor
AstraZeneca
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
387
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Research Site

🇳🇱

Amsterdam, Netherlands

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