A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01427439
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1455

Inclusion Criteria

• Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module)
• Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician
• The patient will present within the normal course of care, for either a first or subsequent episode of depression

Exclusion Criteria

• Schizophrenia or other psychotic disorders
• Bipolar disorder
• Dementia or other neurodegenerative disease significantly impacting cognitive functioning
• Mood disorder due to a general medical condition or substances
• Acute suicidality
• Patient treated for depression by a combination of different antidepressant treatments at the time of the consultation

Other exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score	At baseline
Patients' functioning assessed by the SDS total score	At 12 months

Secondary Outcome Measures

Name	Time	Method
Associations between the patients' clinical condition measured as score on Clinical Global Improvement Severity scale (CGI-S) and of patients' functioning measured as total score on SDS	At baseline
Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS	At 24 months

Trial Locations

Locations (1)

FR; 🇫🇷 Paris, France