NCT01446692

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

First QC Date

September 28, 2011

Last Update Submit

January 11, 2012

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderprimary carereal-world evidencedatabase

Outcome Measures

Primary Outcomes (1)

  • Description of the antidepressant strategies switches

    Number and type of treatment changes including combination, switch, or augmentation strategies.

    18 months

Secondary Outcomes (5)

  • Health care resource utilization

    18 months

  • Health care costs

    18 months

  • Hamilton Depression Rating Scale

    18 months

  • Medication possession rate to evaluate adherence

    18 months

  • Referral to psychiatrist office

    18 months

Study Arms (2)

Patients with suboptimal response

Patients with symptomatic remission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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
  • months of enrollment with medical and pharmacy records after index episode date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Badalona, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 5, 2011

Study Start

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

ES(1)