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

AstraZeneca

Status: Completed

Conditions: Schizophrenia; Mania

Study type: Observational

Funder types: Industry

Identifiers

NCT00534222

NIS-NNL-SER-2005/1

NL 401241 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 387 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

387 participants in 3 patient groups

Quetiapine

Olanzapine

Risperidone