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

Conditions

Major Depressive Disorder

Keywords

MDD, Non-interventional study, Observational study

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.

Haro JM, Hammer-Helmich L, Saragoussi D, Ettrup A, Larsen KG.

2019-08-1321 citations

10.2147/ndt.s206825

Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan (PERFORM-J): Protocol for a Prospective Cohort Study.

Sumiyoshi T, Watanabe K, Noto S, Sakamoto S, Moriguchi Y, Okamoto S.

2018-06-258 citations

10.2196/resprot.9682

Characteristics of patients with depression initiating or switching antidepressant treatment: baseline analyses of the PERFORM cohort study.

Haro JM, Lamy FX, Jönsson B, Knapp M, Brignone M, Caillou H, Chalem Y, Hammer-Helmich L, Rive B, Saragoussi D.

2018-03-278 citations

10.1186/s12888-018-1657-3

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 12 months

Countries

France

Outcome results