Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Recruiting now · Not applicable
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT05866575
- Run by
- Centre Hospitalier St Anne
- People needed
- 136
- Starts
- 2023-09-12
- Expected to finish
- 2026-11-12
- Last updated by the study team
- 2024-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences — Paris, France (enrolling)
- 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
Full record on ClinicalTrials.gov
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