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

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT02051413
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arm: 1
• Actual Duration (Months): 50.4
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Major Depressive Episode	Drug: Venlafaxine extended release	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder
• Actual Study Start Date: Feb 18, 2014
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Venlafaxine extended release Venlafaxine extended-release, flexible dose	Drug: Venlafaxine extended release; antidepressant drug; Other Names: EFFEXOR

Outcome Measures

Primary Outcome Measures

1. Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bicetre	Le Kremlin Bicetre		France	94275

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Emmanuelle Corruble, MD, PhD, Inserm U669, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT02051413
• Other Study ID Numbers: C13-25; 2013-004326-29
• First Posted: Jan 31, 2014
• Last Update Posted: Aug 26, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France: Major depression; Antidepressant drug; Beta-arrestin; Biomarker; Predictive factor
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Venlafaxine Hydrochloride

Study Results

No Results Posted as of Aug 26, 2021