Blood Biomarkers in Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood prelevement
psychometric data collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Major Depressive Disorder focused on measuring Major depression
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
pan-genomic screen
control
Arm 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,
a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02209142
First Posted
August 4, 2014
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02209142
Brief Title
Blood Biomarkers in Major Depression
Official Title
Blood Biomarkers in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2012 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pan-genomic screen
Arm Type
Experimental
Arm 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,
Arm Title
control
Arm Type
Sham Comparator
Arm Description
a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
Intervention Type
Other
Intervention Name(s)
blood prelevement
Intervention Description
blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
Intervention Type
Other
Intervention Name(s)
psychometric data collection
Other Intervention Name(s)
psychometric data collection wil be done ( hamilton scale and clinical exam)
Primary Outcome Measure Information:
Title
describe a transcriptional signature of the Major Depressive Episode.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
evaluate the role played by confounding factors as genetic polymorphisms,
Description
evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
evaluate the role played by confounding factors as immune phenotype
Description
evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression
Time Frame
6 months
Title
evaluate the role played by confounding factors as psychotropic medications
Description
evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean Naudin, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32242018
Citation
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.
Results Reference
derived
Learn more about this trial
Blood Biomarkers in Major Depression
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