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

Completed

• Conditions: Bipolar Disorder; New Occurred Episode

• Registration Number: NCT01029145
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 537

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms severity	10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )

Secondary Outcome Measures

Name	Time	Method
QoL/ quality of life	twice in 10 weeks ( v1 and v4)

Trial Locations

Locations (1)

Research Site; 🇷🇴 Tulcea, Romania