Badalona Major Depressive Disorder Database Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01446692
First received: September 28, 2011
Last updated: January 11, 2012
Last verified: January 2012
  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 ] [ Designated as safety issue: No ]
    Number and type of treatment changes including combination, switch, or augmentation strategies.


Secondary Outcome Measures:
  • Health care resource utilization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Health care costs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Medication possession rate to evaluate adherence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Referral to psychiatrist office [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446692

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01446692     History of Changes
Other Study ID Numbers: NIS-NES-XXX-2011/2
Study First Received: September 28, 2011
Last Updated: January 11, 2012
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014