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

NCT05866575 · Centre Hospitalier St Anne
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Official title
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
About this study
One hundred patients with a moderate to severe major depressive episode will be enrolled in this prospective multicenter study. Six visits will be scheduled within a year: * V0 (inclusion visit): verification of inclusion and exclusion criteria, information, and consent. * V1 (before randomization - baseline state): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Neuro-cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. Part of the tests will be performed during the functional MRI session. * Structural (anatomical) and functional MRI, ASL. * Blood samples. * Randomization and introduction of the new antidepressant will occur immediately after V1. To maximize acceptability by referring psychiatrists, dosage and co-prescriptions will be at the discretion of the psychiatrist in charge, but the assigned treatment will not be changed for 4 weeks (until V3). * V2 (7 days after the beginning of the new antidepressant - 'early response visit'): o Similar to V1. * V3 (28 days after the beginning of the new antidepressant - 'conventional response visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Blood samples * V4 (6 months after the beginning of the new antidepressant - 'remission visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. * Cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. * Structural (anatomical) MRI, ASL * Blood samples * V5 (one year after the beginning of the new antidepressant - 'functional remission visit'): * Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction. 36 healthy volunteers without a history of neurologic or psychiatric disorder, matched for age, gender, and education will be included. They will perform V0-V2 (without MRI and blood sample at V2). Healthy volunteers will not receive any treatment as part of the research.
Eligibility criteria
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
Study design
Enrollment target: 136 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-12
Estimated completion: 2026-11-12
Last updated: 2024-07-10
Interventions
Other: escitalopramOther: vortioxetine
Primary outcomes
  • Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the early changes (differences between V1 and V2) of the computational phenotype of depressed patients. (Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant))
Sponsor
Centre Hospitalier St Anne · other
Contacts & investigators
ContactFabien Vinckier · contact · f.vinckier@ghu-paris.fr · 0033683714083
ContactClaire Jaffré · contact · claire.jaffre@yahoo.fr · 0033650557373
All locations (5)
Groupe hospitalo-universitaire de Grenoble AlpesNot Yet Recruiting
La Tronche, Isère, France
Centre hospitalier Universitaire de LilleNot Yet Recruiting
Lille, Nord, France
Centre hospitalier Universitaire de Saint-EtienneNot Yet Recruiting
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne UniversitéNot Yet Recruiting
Paris, France
- Groupe hospitalo-universitaire Paris Psychiatrie et NeurosciencesRecruiting
Paris, France
Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation · TrialPath