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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427439
First Posted: September 1, 2011
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lundbeck A/S
  Purpose
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.

Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score [ Time Frame: At baseline ]
  • Patients' functioning assessed by the SDS total score [ Time Frame: At 12 months ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 1455
Study Start Date: February 2011
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Depressive Disorder

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427439


Locations
France
FR
Paris, France
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01427439     History of Changes
Other Study ID Numbers: 13504A
First Submitted: August 26, 2011
First Posted: September 1, 2011
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by H. Lundbeck A/S:
MDD
Non-interventional study
Observational study

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms