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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927420
First Posted: June 25, 2009
Last Update Posted: October 30, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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
Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 300
Study Start Date: July 2009
Study Completion Date: October 2009
Groups/Cohorts
1
Patients diagnosed with bipolar disorder I or II (DSM-IV) in ambulatory settings

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  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): 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
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00927420     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2009/1
First Submitted: June 23, 2009
First Posted: June 25, 2009
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