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

NCT ID: NCT01427439

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Major Depressive Disorder

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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FR

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31616147 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29587672 (View on PubMed)

Other Identifiers

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13504A

Identifier Type: -

Identifier Source: org_study_id

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