Blood Biomarkers in Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Other: blood prelevement; Other: psychometric data collection

• Registration Number: NCT02209142
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pan-genomic screen	psychometric data collection	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,
control	psychometric data collection	a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
control	blood prelevement	a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
pan-genomic screen	blood prelevement	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,

Primary Outcome Measures

Name	Time	Method
describe a transcriptional signature of the Major Depressive Episode.	6 months	The major aim of our study is to compare the expression level of selected genes between patient suffering from major depression and control subjects and within patients across the MDE evolution. We plan to describe a transcriptional signature of the MDE.

Secondary Outcome Measures

Name	Time	Method
evaluate the role played by confounding factors as genetic polymorphisms,	6 months	evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France