Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR

AstraZeneca1 site in 1 country537 target enrollmentDecember 2009

ConditionsBipolar Disorder New Occurred Episode

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: AstraZeneca
Enrollment: 537
Locations: 1
Primary Endpoint: Symptoms severity
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Patients eligible for entry into the study, male and females, will have a diagnosis of bipolar disorder, as defined by DSM-IV-TR and the current episode, whether it is manic, depressed or mixed will be treated with Seroquel XR since 1 week before entering the programme.
•All eligible patients will be included in the programme provided they will receive information in advance and will sign consent to grant access to the data collected with regard to their condition during the observation interval proposed.

Exclusion Criteria

•All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
•Concomitant medication, that could result in drug interactions and could jeopardize patient safety will be carefully considered before having the patient enrolled. Additionally, all precautions applicable for special category patients will be taken into account, as detailed in current valid Romanian SmPC.