Badalona Major Depressive Disorder Database Study

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446692
• Other study ID #: NIS-NES-XXX-2011/2
• Status: Completed
• Phase: N/A
• First received: September 28, 2011
• Last updated: January 11, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2260
• Est. completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
Spain	Research Site	Badalona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the antidepressant strategies switches	Number and type of treatment changes including combination, switch, or augmentation strategies.	18 months	No
Secondary	Health care resource utilization		18 months	No
Secondary	Health care costs		18 months	No
Secondary	Hamilton Depression Rating Scale		18 months	No
Secondary	Medication possession rate to evaluate adherence		18 months	No
Secondary	Referral to psychiatrist office		18 months	No