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RECRUITING
NCT05866575
NA

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

Sponsor: Centre Hospitalier St Anne

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2023-09-12

Completion Date

2026-11-12

Last Updated

2024-07-10

Healthy Volunteers

Yes

Interventions

OTHER

escitalopram

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.

OTHER

vortioxetine

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