NCT02051413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 major-depressive-disorder

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

February 18, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

January 22, 2014

Last Update Submit

August 25, 2025

Conditions

Major Depressive DisorderMajor Depressive Episode

Keywords

Major depressionAntidepressant drugBeta-arrestinBiomarkerPredictive factor

Outcome Measures

Primary Outcomes (1)

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

    3 months

Study Arms (1)

Venlafaxine extended release

OTHER

Venlafaxine extended-release, flexible dose

Drug: Venlafaxine extended release

Interventions

Venlafaxine extended releaseDRUG

antidepressant drug

Also known as: EFFEXOR
Venlafaxine extended release

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major Depressive Disorder
  • current Major Depressive Episode
  • Hamilton Depression Rating Scale score \> 18
  • requiring a new treatment with venlafaxine
  • written informed consent

You may not qualify if:

  • bipolar disorder
  • psychotic disorder
  • unstable somatic condition
  • contraindication to cerebral RMI
  • current treatment with mood stabilizers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Related Publications (5)

  • Colle R, El Asmar K, Verstuyft C, Lledo PM, Lazarini F, Chappell K, Deflesselle E, Ait Tayeb AEK, Falissard B, Duron E, Rotenberg S, Costemale-Lacoste JF, David DJ, Gressier F, Gardier AM, Hummel T, Becquemont L, Corruble E. The olfactory deficits of depressed patients are restored after remission with venlafaxine treatment. Psychol Med. 2020 Oct 22:1-9. doi: 10.1017/S0033291720003918. Online ahead of print.

    PMID: 33087184BACKGROUND

  • Baudouin E, Corruble E, Gori P, Bloch I, Becquemont L, Duron E, Colle R. White matter hyperintensities and their role in major depressive episodes: a cross-sectional study in adults under 65. Braz J Psychiatry. 2025;47:e20243921. doi: 10.47626/1516-4446-2024-3921. Epub 2024 Dec 28.

    PMID: 39731725BACKGROUND

  • Mesdom P, Colle R, Becquemont L, Chappell K, David DJ, Mendez-David I, Corruble E, Verstuyft C. Tobacco use is associated with low peripheral beta-arrestin 1 levels in major depression: A preliminary report. Drug Alcohol Depend. 2022 Nov 1;240:109653. doi: 10.1016/j.drugalcdep.2022.109653. Epub 2022 Oct 2.

    PMID: 36209675BACKGROUND

  • Etienne J, Boutigny A, David DJ, Deflesselle E, Gressier F, Becquemont L, Corruble E, Colle R. Habenular volume changes after venlafaxine treatment in patients with major depression. Psychiatry Clin Neurosci. 2024 Aug;78(8):468-472. doi: 10.1111/pcn.13684. Epub 2024 Jun 12.

    PMID: 38867362BACKGROUND

  • Cussotto S, Colle R, Voican CS, Ciocan DM, Trainel N, Bottemanne H, Pelloux Y, David DJ, Cassard AM, Perlemuter G, Corruble E. The Gut Microbiota Is Altered in Antidepressant-Free Depressed Patients and Is Associated With Depression Severity. J Neurochem. 2025 Jul;169(7):e70173. doi: 10.1111/jnc.70173.

    PMID: 40717539BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Emmanuelle Corruble, MD, PhD

    Inserm U669, APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 31, 2014

Study Start

February 18, 2014

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 2, 2025

Record last verified: 2021-08

Locations

FR(1)