Predicting how well antidepressants will work based on motivation assessment
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
This study is testing whether measuring motivation can help predict how well antidepressants work for people with major depressive disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 5 sites (La Tronche, Isère and 4 other locations) |
| Trial ID | NCT05866575 on ClinicalTrials.gov |
What this trial studies
This study investigates the mechanisms of action of antidepressants by assessing motivation deficits in patients with major depressive disorder. One hundred participants will be enrolled and randomized to receive either escitalopram or vortioxetine, with their responses monitored through a series of evaluations over one year. The study employs neurocomputational modeling and functional MRI to identify brain correlates of motivation before and during treatment. Additionally, 36 healthy volunteers will be included for comparative analysis.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate to severe major depressive disorder who require a new line of treatment.
Not a fit: Patients with treatment-resistant depression or those who have previously tried escitalopram or vortioxetine for their current episode may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with major depressive disorder.
How similar studies have performed: While the approach of using neurocomputational modeling in this context is relatively novel, similar studies have shown promise in understanding treatment responses in depression.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Tronche, Isère and 4 other locations
- Groupe hospitalo-universitaire de Grenoble Alpes — La Tronche, Isère, France (Not_yet_recruiting)
- Centre hospitalier Universitaire de Lille — Lille, Nord, France (Not_yet_recruiting)
- Centre hospitalier Universitaire de Saint-Etienne — Saint-Priest-en-Jarez, Pays de la Loire Region, France (Not_yet_recruiting)
- Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université — Paris, France (Not_yet_recruiting)
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences — Paris, France (Recruiting)
Study contacts
- Study coordinator: Fabien Vinckier
- Email: f.vinckier@ghu-paris.fr
- Phone: 0033683714083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.