Clinical trial NCT02051413: Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN)
Official title: Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Major Depressive Episode
Keywords: Major depression
Antidepressant drug
Beta-arrestin
Biomarker
Predictive factor
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-01-31
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: CHU de Bicetre
Study officials:
affiliation: Inserm U669, APHP
name: Emmanuelle Corruble, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: