NCT02209142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

10.7 years

First QC Date

August 4, 2014

Last Update Submit

April 20, 2023

Conditions

Keywords

Major depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate the role played by confounding factors as genetic polymorphisms,

    6 months

Other Outcomes (2)

  • evaluate the role played by confounding factors as immune phenotype

    6 months

  • evaluate the role played by confounding factors as psychotropic medications

    6 months

Study Arms (2)

pan-genomic screen

EXPERIMENTAL

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 prelevementOther: psychometric data collection

control

SHAM COMPARATOR

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

Other: blood prelevementOther: psychometric data collection

Interventions

blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks

controlpan-genomic screen
Also known as: psychometric data collection wil be done ( hamilton scale and clinical exam)
controlpan-genomic screen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Taken care by a grown-up psychiatric department, that the coverage(care) is realized in ambulatory or during a hospitalization

You may not qualify if:

  • Schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13009, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • jean Naudin, MD

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 5, 2014

Study Start

February 22, 2012

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations