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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 ] [ Designated as safety issue: No ]
  • Patients' functioning assessed by the SDS total score [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Estimated Enrollment: 2000
Study Start Date: February 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Depressive Disorder

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427439

Contacts
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01427439     History of Changes
Other Study ID Numbers: 13504A
Study First Received: August 26, 2011
Last Updated: March 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Germany: Ethics Commission
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 01, 2014