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

Lundbeck

Status: Completed

Conditions: Major Depressive Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01427439

13504A

Details and patient eligibility

About

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

Enrollment: 1,455 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,455 participants in 1 patient group

Major Depressive Disorder