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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01062607
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bipolar Disorders

Study Design

Study Type : Observational
Actual Enrollment : 2965 participants
Observational Model: Cohort
Official Title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)
Study Start Date : April 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 .


Outcome Measures

Primary Outcome Measures :
  1. Demographic variables [ Time Frame: Once during study ]
  2. 1-year prevalence for each disease phase [ Time Frame: everytime the patient attends the consult ]

Secondary Outcome Measures :
  1. Use of resources [ Time Frame: everytime the patient attends the consult ]
  2. treatments prescribed, EQ5D [ Time Frame: everytime the patient attends the consult ]
  3. treatments prescribed, FAST [ Time Frame: everytime the patient attends the consult ]
  4. treatments prescribed, DAI-10 [ Time Frame: everytime the patient attends the consult ]
  5. treatments prescribed, MPR [ Time Frame: everytime the patient attends the consult ]
  6. treatments prescribed, BAS [ Time Frame: Once during the prospective part (only if patient attends with a caregiver) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062607


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

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
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders