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

Major Depressive Disorder Clinical Trial

— PERFORM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427439
• Other study ID #: 13504A
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: July 7, 2015
• Start date: February 2011

Study information

• Verified date: July 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• 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 santéFrance: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des MédecinsFrance: The Commission nationale de l’informatique et des libertésGermany: Ethics CommissionSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1455
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
France	FR	Paris

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score		At baseline	No
Primary	Patients' functioning assessed by the SDS total score		At 12 months	No
Secondary	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		At baseline	No
Secondary	Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS		At 12 months	No
Secondary	Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS		At 24 months	No