Blood Biomarkers in Major Depression

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Other: blood prelevement; Other: psychometric data collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02209142

2010-19

Details and patient eligibility

About

Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.

Enrollment: 275 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Major depressive disorder at inclusion according to the DSM IV at the time of the inclusion,

  • Having a score on the scale of depression of Hamilton ( HDRS-17) > 19 at the time of the inclusion,
  • Taken care by a grown-up psychiatric department, that the coverage(care) is realized in ambulatory or during a hospitalization

Exclusion criteria

• Schizophrenia

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

275 participants in 2 patient groups

pan-genomic screen

Experimental group

Description:

A pan-genomic screen by blood prelevement and psychometric data collection will be set-up on a subset of MDE and control samples to identify mRNA candidates for a transcriptional signature of MDE,

Treatment:

Other: psychometric data collection

Other: blood prelevement

control

Sham Comparator group

Description:

a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject

Treatment:

Other: psychometric data collection

Other: blood prelevement