Blood Biomarkers in Major Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: blood prelevement; Other: psychometric data collection

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pan-genomic screen; 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,	Other: blood prelevement; blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks; Other: psychometric data collection; Other Names: psychometric data collection wil be done ( hamilton scale and clinical exam)
Sham Comparator: control; a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject	Other: blood prelevement; blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks; Other: psychometric data collection; Other Names: psychometric data collection wil be done ( hamilton scale and clinical exam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
describe a transcriptional signature of the Major Depressive Episode.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the role played by confounding factors as genetic polymorphisms,	evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the role played by confounding factors as immune phenotype	evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression	6 months
evaluate the role played by confounding factors as psychotropic medications	evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: jean Naudin, MD, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2012
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Major depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2010-19