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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Patients with major depressive disorder Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Who May Qualify: \- Valid health care insurance Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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