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Completed

NCT Number: NCT01062607

Study of the Clinical Management of Bipolar Disease

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.

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Key information

Conditions

Bipolar Disorders Behavior Bipolar Disorder Bipolar and Related Disorders Health Behavior Mental Disorders Mood Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: WAVE bd

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2010
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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