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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
August 26, 2011
September 1, 2011
July 8, 2015
February 2011
February 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01427439 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)
Major Depressive Disorder
Not Provided
Major Depressive Disorder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1455
Not Provided
February 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01427439
13504A
No
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
July 2015