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

Primary Purpose

Major Depressive Disorder, Major Depressive Episode

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Venlafaxine extended release
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depression, Antidepressant drug, Beta-arrestin, Biomarker, Predictive factor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bicetre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Venlafaxine extended release

Arm Description

Venlafaxine extended-release, flexible dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 22, 2014
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02051413
Brief Title
Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN)
Acronym
DEPARRESTCLIN
Official Title
Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Major Depressive Episode
Keywords
Major depression, Antidepressant drug, Beta-arrestin, Biomarker, Predictive factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venlafaxine extended release
Arm Type
Other
Arm Description
Venlafaxine extended-release, flexible dose
Intervention Type
Drug
Intervention Name(s)
Venlafaxine extended release
Other Intervention Name(s)
EFFEXOR
Intervention Description
antidepressant drug
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Corruble, MD, PhD
Organizational Affiliation
Inserm U669, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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