Blood Biomarkers in Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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Blood Biomarkers in Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: blood prelevement
* Other: psychometric data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression