Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR

AstraZeneca

Status: Completed

Conditions: New Occurred Episode; Bipolar Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01029145

NIS-NRO-SER-2009/1

Details and patient eligibility

About

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

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

537 participants in 1 patient group

1

Description:

Bipolar patients that experience a new episode of any type