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Badalona Major Depressive Disorder Database Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446692
First Posted: October 5, 2011
Last Update Posted: January 12, 2012
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 (Responsible Party):
AstraZeneca
  Purpose
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care

Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of the antidepressant strategies switches [ Time Frame: 18 months ]
    Number and type of treatment changes including combination, switch, or augmentation strategies.


Secondary Outcome Measures:
  • Health care resource utilization [ Time Frame: 18 months ]
  • Health care costs [ Time Frame: 18 months ]
  • Hamilton Depression Rating Scale [ Time Frame: 18 months ]
  • Medication possession rate to evaluate adherence [ Time Frame: 18 months ]
  • Referral to psychiatrist office [ Time Frame: 18 months ]

Enrollment: 2260
Study Start Date: November 2011
Study Completion Date: January 2012
Groups/Cohorts
Patients with suboptimal response
Patients with symptomatic remission

Detailed Description:
Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study
  Eligibility

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
Primary care clinic
Criteria

Inclusion Criteria:

  • An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
  • At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
  • 18 months of enrollment with medical and pharmacy records after index episode date
  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): NCT01446692


Locations
Spain
Research Site
Badalona, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01446692     History of Changes
Other Study ID Numbers: NIS-NES-XXX-2011/2
First Submitted: September 28, 2011
First Posted: October 5, 2011
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Major depressive disorder
primary care
real-world evidence
database

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms