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

H. Lundbeck A/S1 site in 1 country1,455 target enrollmentFebruary 2011

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Enrollment: 1455
Locations: 1
Primary Endpoint: Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

February 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score

Time Frame: At baseline

Patients' functioning assessed by the SDS total score

Time Frame: At 12 months

Secondary Outcomes

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)