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

RECRUITINGN/ASponsored by Centre Hospitalier St Anne
Actively Recruiting
PhaseN/A
SponsorCentre Hospitalier St Anne
Started2023-09-12
Est. completion2026-10-12
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
Patients with major depressive disorder

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

Conditions2

DepressionMajor Depressive Disorder

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