RecruitingNot ApplicableNCT05866575

Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation

Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation

Sponsor

Centre Hospitalier St Anne

Enrollment

136 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Patients with major depressive disorder
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
\- Valid health care insurance

Exclusion Criteria12

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
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

Interventions

OTHERescitalopram

Patients will receive an antidepressant strategy : escitalopram. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.

OTHERvortioxetine

Patients will receive an antidepressant strategy : vortioxetine. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the treatment strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.