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

Phase 4

Completed

• Conditions: Major Depressive Disorder; Major Depressive Episode
• Interventions: Drug: Venlafaxine extended release

• Registration Number: NCT02051413
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-02-18
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venlafaxine extended release	Venlafaxine extended release	Venlafaxine extended-release, flexible dose

Primary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items	3 months

Trial Locations

Locations (1)

CHU de Bicetre; 🇫🇷 Le Kremlin Bicetre, France