Predicting Depression Treatment Response Using Motivation Brain Testing
Tests escitalopram and vortioxetine in adults with moderate to severe major depression.
Plain-language title generated from the registry record
Registry title: Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Key facts
- Where
- La Tronche, Lille, Paris, and Saint-Priest-en-Jarez, FranceSee the 5 sites
Where in France
- Groupe hospitalo-universitaire de Grenoble AlpesLa Tronche, FranceNot yet recruiting
- Centre Hospitalier Universitaire de LilleLille, FranceNot yet recruiting
- - Groupe hospitalo-universitaire Paris Psychiatrie et NeurosciencesParis, FranceTaking people
- Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne UniversitéParis, FranceNot yet recruiting
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier St Anne
- Trial code
- NCT05866575
- Record updated
- 10 July 2024
- Original description
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.Read full original descriptionShow less
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
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.
Inclusion: 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; Valid health care insurance.
Exclusion: Subjects with a trial of escitalopram and/or vortioxetine for the current episode, or with contra-indication to one of these two drugs; Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants; Contraindications to MRI scanning: pregnancy, claustrophobia, metallic implants; 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; 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; Treatment-resistant depression (defined as insufficient response despite at least 2 trials of antidepressant prescribed at adequate dose and duration); Pregnant or breastfeeding women; involuntary hospitalisation and legal protection measures; Healthy volunteers; Pregnant or breastfeeding women.
Patients with major depressive disorder.