Clinical trial NCT01427439: A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
Official title: A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: MDD
Non-interventional study
Observational study
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 1455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)

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.


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.

Primary outcomes:
measure: Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
timeFrame: At baseline
measure: Patients' functioning assessed by the SDS total score
timeFrame: At 12 months
Secondary outcomes:
measure: 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
timeFrame: At baseline
measure: Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
timeFrame: At 12 months
measure: Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
timeFrame: At 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: FR
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Haro JM, Hammer-Helmich L, Saragoussi D, Ettrup A, Larsen KG. Patient-reported depression severity and cognitive symptoms as determinants of functioning in patients with major depressive disorder: a secondary analysis of the 2-year prospective PERFORM study. Neuropsychiatr Dis Treat. 2019 Aug 13;15:2313-2323. doi: 10.2147/NDT.S206825. eCollection 2019.
citation: Haro JM, Lamy FX, Jonsson B, Knapp M, Brignone M, Caillou H, Chalem Y, Hammer-Helmich L, Rive B, Saragoussi D. Characteristics of patients with depression initiating or switching antidepressant treatment: baseline analyses of the PERFORM cohort study. BMC Psychiatry. 2018 Mar 27;18(1):80. doi: 10.1186/s12888-018-1657-3.