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

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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

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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