Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Recruiting · NCT05866575 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Meeting DSM-5 criteria for major depressive disorder (single or recurrent episodes)
- With a MADRS score \>= 24
- For which a new line of treatment is needed
- No previous line of antidepressant for this episode or wash-out long-enough to avoid carry-over effects
- Valid health care insurance
Exclusion criteria
- Treatment-resistant depression (defined as insufficient response despite at least 2 trials of antidepressant prescribed at adequate dose and duration)
- Subjects with a trial of escitalopram and/or vortioxetine for the current episode, or with contra-indication to one of these two drugs
- Subjects with a diagnostic of persistent depressive disorder, bipolar disorder or schizophrenia, neurodeveloppemental disorder, unremitted substance abuse disorder other than tobacco, personality disorder severe enough to compromise the follow-up (based on investigator's appreciation).
- Subject with a history of neurological disorder: parkinson's disease, dementia
- Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants
- Pregnant or breastfeeding women
- involuntary hospitalisation and legal protection measures
- Healthy volunteers
- Inclusion Criteria:
- \- Valid health care insurance
- Exclusion Criteria:
- Subjects with a diagnostic of persistent depressive disorder, bipolar disorder or schizophrenia, neurodeveloppemental disorder, unremitted substance abuse disorder other than tobacco, personality disorder severe enough to compromise the follow-up (based on investigator's appreciation).
- Subject with a history of neurological disorder: parkinson's disease, dementia
- Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants
- Pregnant or breastfeeding women
Where it is running
5 locations listed.
- Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université - Paris, France
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences - Paris, France
- Groupe hospitalo-universitaire de Grenoble Alpes - La Tronche, Isère, France
- Centre hospitalier Universitaire de Lille - Lille, Nord, France
- Centre hospitalier Universitaire de Saint-Etienne - Saint-Priest-en-Jarez, Pays de la Loire Region, France