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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
History of Changes
  Purpose

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.


Condition
Mania
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Enrollment: 387
Study Start Date: September 2005
Study Completion Date: December 2007
Groups/Cohorts
Quetiapine
Olanzapine
Risperidone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Psychiatrist' patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534222

Locations
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, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Medical Director AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534222     History of Changes
Other Study ID Numbers: NIS-NNL-SER-2005/1, NL 401241
Study First Received: September 20, 2007
Last Updated: December 13, 2011
Health Authority: Not required for this study:

Keywords provided by AstraZeneca:
Patients with a manic episode
Patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the CGI at baseline

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Quetiapine
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 19, 2013