Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder (MDD) (DEPARRESTCLIN) (DEPARRESTCLIN)
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|ClinicalTrials.gov Identifier: NCT02051413|
Recruitment Status : Unknown
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : January 31, 2014
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Major Depressive Episode||Drug: Venlafaxine extended release||Phase 4|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beta-arrestins and Response to Venlafaxine in Major Depressive Disorder|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2017|
Venlafaxine extended release
Venlafaxine extended-release, flexible dose
Drug: Venlafaxine extended release
Other Name: EFFEXOR
- Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale-17 items [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051413
|Contact: Emmanuelle Corruble, MD, PhDemail@example.com|
|CHU de Bicetre||Recruiting|
|Le Kremlin Bicetre, France, 94275|
|Principal Investigator: Emmanuelle Corruble, MD, PhD|
|Principal Investigator:||Emmanuelle Corruble, MD, PhD||Inserm U669, APHP|