Study of the Clinical Management of Bipolar Disease (WAVE bd)

AstraZeneca

Status: Completed

Conditions: Bipolar Disorders

Study type: Observational

Funder types: Industry

Identifiers

NCT01062607

NIS-NEU-DUM-2009/1

Details and patient eligibility

About

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.

Enrollment: 2,965 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

2,965 participants in 2 patient groups

1

Description:

Patients diagnosed with Bipolar Disorder I or II (DSM-IV-TR) at any phase of the disorder with at least one mood event during the 12 months before the study start.

2

Description:

Patients diagnosed with Bipolar Disorder I or II (DSM-IV-TR) at any phase of the disorder with at least one mood event during the 12 months before the study start receiving Seroquel extended release at some point during the retrospective period .