Blood Biomarkers in Major Depression
1 other identifier
interventional
275
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Feb 2012
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2012
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2022
CompletedApril 21, 2023
April 1, 2023
10.7 years
August 4, 2014
April 20, 2023
Conditions
Keywords
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
EXPERIMENTALA 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
SHAM COMPARATORa pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
Interventions
blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
Eligibility Criteria
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
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.
PMID: 32242018DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jean Naudin, MD
Assistance Publique Hopitaux De Marseille
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