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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00927420
First received: June 23, 2009
Last updated: October 29, 2009
Last verified: October 2009
History of Changes
  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:

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morisky-Green Scale [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]
  • Drug Attitude Inventory Scale (DAI-10) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]
  • Functioning Assessment Short Test (FAST) [ Time Frame: Once, at the visit moment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00927420     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2009/1
Study First Received: June 23, 2009
Last Updated: October 29, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

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

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

ClinicalTrials.gov processed this record on May 22, 2013