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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Key information

Conditions

Mania Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alkmaar, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: UPTAQE

Important dates

Study start: 2005
Study completion: 2007
First posted: Sep 24, 2007
Registry last updated: Dec 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed