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
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