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Completed

NCT Number: NCT01427439

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

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

FR

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At baseline

  2. Patients' functioning assessed by the SDS total score

    Time frame: At 12 months

Secondary outcomes

  1. 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

    Time frame: At baseline

  2. Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS

    Time frame: At 12 months

  3. Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS

    Time frame: At 24 months

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Acronym: PERFORM

Important dates

Study start
2011
Primary completion
2015
First posted
Sep 1, 2011
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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