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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02051413
Other study ID # C13-25
Secondary ID 2013-004326-29
Status Completed
Phase Phase 4
First received
Last updated
Start date February 18, 2014
Est. completion date May 2018

Study information

Verified date August 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
Venlafaxine extended release
antidepressant drug

Locations

Country Name City State
France CHU de Bicetre Le Kremlin Bicetre

Sponsors (1)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items 3 months
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