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

AstraZeneca1 site in 1 country387 target enrollmentSeptember 2005

ConditionsMania Schizophrenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mania
Sponsor: AstraZeneca
Enrollment: 387
Locations: 1
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

December 2007

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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