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Completed

NCT Number: NCT02051413

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Major Depressive Episode Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Bicetre

Le Kremlin-Bicêtre, 94275, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venlafaxine Extended Release

Drug

antidepressant drug

Other names: EFFEXOR

Primary outcomes

  1. Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder

Acronym: DEPARRESTCLIN

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2014
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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