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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01029145

Enrollment

537

Registered

2009-12-09

Start date

2009-12-31

Completion date

2010-05-31

Last updated

2010-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, New Occurred Episode

Keywords

Bipolar disorder, New occured episode: manic depressive or mixed

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Symptoms severity	10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )

Secondary

Measure	Time frame
QoL/ quality of life	twice in 10 weeks ( v1 and v4)

Countries

Romania

Outcome results