Actively Recruiting
Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Led by Centre Hospitalier St Anne · Updated on 2024-07-10
136
Participants Needed
5
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to better understand the mechanisms of action of antidepressants, but also the neural correlates of motivation deficits. One hundred patients with a moderate to severe major depressive episode will be enrolled in this prospective multicenter study. The objective will be to predict the therapeutic response to two first-line antidepressants on the basis of an early neurocomputational assessment of motivation. Antidepressant treatment will be administered as monotherapy after randomization between two drugs: escitalopram and vortioxetine. Patients will undergo six visits and follow-up for one year. The investigators will combine computer modeling and functional MRI to identify motivational deficits and elucidate their brain correlates before initiation, after 7 days and after 6 months of treatment. 36 healthy volunteers will also be included to allow comparison with patients with depression. They will not receive any treatment.
CONDITIONS
Official Title
Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with major depressive disorder according to DSM-5 criteria (single or recurrent episodes)
- MADRS score of 24 or higher
- Need for a new line of antidepressant treatment
- No prior antidepressant treatment for this episode or sufficient wash-out period
- Valid health care insurance
You will not qualify if you...
- Treatment-resistant depression with insufficient response after at least 2 adequate antidepressant trials
- Previous treatment with escitalopram or vortioxetine for the current episode, or contraindication to these drugs
- Diagnosis of persistent depressive disorder, bipolar disorder, schizophrenia, neurodevelopmental disorder, unremitted substance abuse (except tobacco), or severe personality disorder
- History of neurological disorder such as Parkinson's disease or dementia
- Contraindications to MRI (pregnancy, claustrophobia, metallic implants)
- Pregnant or breastfeeding women
- Involuntary hospitalization or under legal protection measures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Groupe hospitalo-universitaire de Grenoble Alpes
La Tronche, Isère, France, 38700
Not Yet Recruiting
2
Centre hospitalier Universitaire de Lille
Lille, Nord, France, 59000
Not Yet Recruiting
3
Centre hospitalier Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
Not Yet Recruiting
4
Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université
Paris, France, 75013
Not Yet Recruiting
5
- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
Paris, France, 75014
Actively Recruiting
Research Team
F
Fabien Vinckier
CONTACT
C
Claire Jaffré
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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