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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00534222
First received: September 20, 2007
Last updated: December 13, 2011
Last verified: April 2009

September 20, 2007
December 13, 2011
September 2005
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Complete list of historical versions of study NCT00534222 on ClinicalTrials.gov Archive Site
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Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Psychiatrist' patients

  • Mania
  • Schizophrenia
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  • Quetiapine
  • Olanzapine
  • Risperidone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
387
December 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00534222
NIS-NNL-SER-2005/1, NL 401241
No
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AstraZeneca
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Study Director: Medical Director AstraZeneca
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP