Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN)

Study Overview
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Brief Summary
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Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors. The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder. In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed. The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.

Detailed Description
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Rationale: Predictive factors and biomarkers of response to antidepressants in major depressive disorder are scarce. Beta-arrestins are proteins which inhibit G Protein Coupled Receptors and desensitize serotonergic and dopaminergic receptors. Hypothesis: The study hypothesis is that Beta-arrestins 1 and 2 are predictive factors and biomarkers of response to antidepressants in major depressive disorder. Method: In a controlled prospective open naturalistic monocentric 3-month study, 60 patients with a major depressive disorder requiring a treatment with venlafaxine will be included and assessed before treatment, 1 month and 3 months post-treatment. 20 controlled healthy subjects matched for age and gender will also be assessed. Assessments: The Beta-arrestin pathway will be assessed using genetic polymorphisms, Peripheral Blood Mononuclear Cell measures and functional pathway. Antidepressant response will be assessed using depression scales, olfaction and memory as surrogate markers of neurogenesis.

Official Title
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Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder

Conditions
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Major Depressive Disorder, Major Depressive Episode

Intervention / Treatment
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* Drug: Venlafaxine extended release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depressive Disorder current Major Depressive Episode Hamilton Depression Rating Scale score > 18 requiring a new treatment with venlafaxine written informed consent Exclusion Criteria: bipolar disorder psychotic disorder unstable somatic condition contraindication to cerebral RMI current treatment with mood stabilizers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Venlafaxine extended release<br>Venlafaxine extended-release, flexible dose | Drug: Venlafaxine extended release<br>* antidepressant drug<br>* Other names: EFFEXOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression, Antidepressant drug, Beta-arrestin, Biomarker, Predictive factor