NCT05866575Recruiting
Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
Source: ClinicalTrials.gov · Last updated 10 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 15 Nov 2022
- Start date
- 12 Sept 2023
- Primary completion date
- 12 Oct 2026
- Lead sponsor
- Centre Hospitalier St Anne
- Diseases
- Depression
- NCT number
- NCT05866575
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 12 Sept 2023 to the primary completion date, 12 Oct 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- Patients with major depressive disorder
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groupe hospitalo-universitaire de Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.