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

Information source: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Major Depressive Episode

Intervention: Venlafaxine extended release (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Institut National de la Santé Et de la Recherche Médicale, France

Official(s) and/or principal investigator(s):
Emmanuelle Corruble, MD, PhD, Principal Investigator, Affiliation: Inserm U669, APHP

Overall contact:
Emmanuelle Corruble, MD, PhD, Phone: 0145212524, Email: emmanuelle.corruble@bct.aphp.fr

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Emmanuelle Corruble, MD, PhD, Phone: 0145212524, Email: emmanuelle.corruble@bct.aphp.fr

CHU de Bicetre, Le Kremlin Bicetre 94275, France; Not yet recruiting
Emmanuelle Corruble, MD, PhD, Principal Investigator
Additional Information

Starting date: February 2014
Last updated: January 30, 2014

Page last updated: August 23, 2015

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