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

This study is currently recruiting participants.
Verified March 2014 by H. Lundbeck A/S
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01427439
First received: August 26, 2011
Last updated: March 20, 2014
Last verified: March 2014

August 26, 2011
March 20, 2014
February 2011
December 2014   (final data collection date for primary outcome measure)
  • Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Patients' functioning assessed by the SDS total score [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
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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.
 
Recruiting
2000
Not Provided
December 2014   (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.

Both
18 Years to 65 Years
No
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
France
 
NCT01427439
13504A
No
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
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP