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

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

Plain Language Summary

Simplified for easier understanding

This study uses brain scans and computer-based tests to see if a person's motivation patterns (measured through brain activity) can predict which antidepressant medication will work best for them. Healthy volunteers are also enrolled for comparison. **You may be eligible if you have depression and...** - You have a current diagnosis of major depressive disorder that is moderate to severe - You need to start a new treatment (no previous antidepressant tried for this episode, or long enough off prior treatment) - You have valid health insurance **You may NOT be eligible if...** - You have treatment-resistant depression (failed 2 or more adequate antidepressant trials) - You have bipolar disorder, schizophrenia, dementia, or Parkinson's disease - You have contraindications to MRI (metal implants, claustrophobia) or are pregnant - You have a severe substance use disorder **Healthy volunteers** may also join if they have no mental health diagnoses, no neurological conditions, and can have an MRI. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(5)

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

Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université

Paris, France

- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

Paris, France

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NCT05866575


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