Beta-arrestins and Response to Venlafaxine in Major Depre... | NCT02051413

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

NCT02051413

Sponsor

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

Status

Completed

Last Update Posted

Sep 2, 2025Actual

Enrollment

67Actual

Phase

Phase 4

Conditions

Major Depressive Disorder
Major Depressive Episode

Interventions

Venlafaxine extended release

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-004326-29	EudraCT Number

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2014Actual

Primary Completion Date

May 2018Actual

Completion Date

May 2018Actual

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Jan 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venlafaxine extended release	Other	Venlafaxine extended-release, flexible dose	Drug: Venlafaxine extended release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venlafaxine extended release	Drug	antidepressant drug	Venlafaxine extended release

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuelle Corruble, MD, PhD	Inserm U669, APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bicetre		Le Kremlin-Bicêtre		94275	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33087184	Result	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. 2022 Aug;52(11):2062-2070. doi: 10.1017/S0033291720003918. Epub 2020 Oct 22.
39731725

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930