NCT05866575 Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
| NCT ID | NCT05866575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2026-10-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2023-09-12 with a primary completion date of 2026-10-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05866575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05866575 currently recruiting?
Yes, NCT05866575 is actively recruiting participants. Contact the research team at f.vinckier@ghu-paris.fr for enrollment information.
Where is the NCT05866575 trial being conducted?
This trial is being conducted at La Tronche, France, Lille, France, Saint-Priest-en-Jarez, France, Paris, France and 1 additional location.
Who is sponsoring the NCT05866575 clinical trial?
NCT05866575 is sponsored by Centre Hospitalier St Anne. The trial plans to enroll 136 participants.