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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01062607
First received: January 27, 2010
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition
Bipolar Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Demographic variables [ Time Frame: Once during study ] [ Designated as safety issue: No ]
  • 1-year prevalence for each disease phase [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of resources [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]
  • treatments prescribed, EQ5D [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]
  • treatments prescribed, FAST [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]
  • treatments prescribed, DAI-10 [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]
  • treatments prescribed, MPR [ Time Frame: everytime the patient attends the consult ] [ Designated as safety issue: No ]
  • treatments prescribed, BAS [ Time Frame: Once during the prospective part (only if patient attends with a caregiver) ] [ Designated as safety issue: No ]

Enrollment: 2965
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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
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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Bipolar patients seen in mental health centers, clinics, private settings, hospitals or specialized units

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062607

  Show 213 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Esteban Medina Medical Department.AstraZeneca Spain
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01062607     History of Changes
Other Study ID Numbers: NIS-NEU-DUM-2009/1
Study First Received: January 27, 2010
Last Updated: May 22, 2012
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
France: French Data Protection Authority
France: Institutional Ethical Committee
Turkey: Ministry of Health
Germany: Ethics Commission
Portugal: Ethics Committee for Clinical Research
Spain: Ethics Committee
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Venezuela: Ethics Committee
Romania: Ministry of Public Health
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
bipolar disorders
everyday setting
treatment adherence
global

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014