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Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

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ClinicalTrials.gov Identifier: NCT00927420
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : October 30, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.

Condition or disease
Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
Study Start Date : July 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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

Group/Cohort
1
Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings



Primary Outcome Measures :
  1. Morisky-Green Scale [ Time Frame: Once, at the visit moment ]
  2. Drug Attitude Inventory Scale (DAI-10) [ Time Frame: Once, at the visit moment ]

Secondary Outcome Measures :
  1. Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M) [ Time Frame: Once, at the visit moment ]
  2. Functioning Assessment Short Test (FAST) [ Time Frame: Once, at the visit moment ]


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:   Non-Probability Sample
Study Population
Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings
Criteria

Inclusion Criteria:

  • Patients diagnosed with bipolar disorder I or II DSM-IV
  • Patients treated with at least one oral antipsychotic
  • Subjects able to read and write

Exclusion Criteria:

  • Patients participating in clinical trials

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): NCT00927420


Locations
Spain
Research Site
Langreo, Asturias, Spain
Research Site
Las Palmas, Gran Canarias, Spain
Research Site
Calahorra, La Rioja, Spain
Research Site
La Laguna, Tenerife, Spain
Research Site
Alicante, Spain
Research Site
Almeria, Spain
Research Site
Badajoz, Spain
Research Site
Barcelona, Spain
Research Site
Cordoba, Spain
Research Site
Elche, Spain
Research Site
Leon, Spain
Research Site
Lerida, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Murcia, Spain
Research Site
Orense, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Salamanca, Spain
Research Site
Sevilla, Spain
Research Site
Toledo, Spain
Research Site
Valencia, Spain
Research Site
Valladolid, Spain
Research Site
Vitoria, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Elisa Gil AstraZeneca Spain EpidemiologyValue Demonstration Unit

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00927420     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2009/1
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Keywords provided by AstraZeneca:
Bipolar disorder
adherence
treatment
real life practice

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders