Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

AstraZeneca1 site in 1 country2,965 target enrollmentApril 2010

ConditionsBipolar Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bipolar Disorders
Sponsor: AstraZeneca
Enrollment: 2965
Locations: 1
Primary Endpoint: Demographic variables
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

June 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder
•Patients who had at least one mood event (depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 12 months prior to the beginning of the study

Exclusion Criteria

•Patients who had the index mood event during the 3 months before the beginning of the study (Time 0).

Outcomes

Primary Outcomes

Demographic variables

Time Frame: Once during study

1-year prevalence for each disease phase

Time Frame: everytime the patient attends the consult

Secondary Outcomes

Use of resources(everytime the patient attends the consult)
treatments prescribed, EQ5D(everytime the patient attends the consult)
treatments prescribed, FAST(everytime the patient attends the consult)
treatments prescribed, DAI-10(everytime the patient attends the consult)
treatments prescribed, MPR(everytime the patient attends the consult)
treatments prescribed, BAS(Once during the prospective part (only if patient attends with a caregiver))