Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
NCT ID: NCT05866575
Last Updated: 2024-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
136 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-12
Study Completion Date
2026-11-12
Brief Summary
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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.
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Detailed Description
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One hundred patients with a moderate to severe major depressive episode will be enrolled in this prospective multicenter study. Six visits will be scheduled within a year:
* V0 (inclusion visit): verification of inclusion and exclusion criteria, information, and consent.
* V1 (before randomization - baseline state):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Neuro-cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. Part of the tests will be performed during the functional MRI session.
* Structural (anatomical) and functional MRI, ASL.
* Blood samples.
* Randomization and introduction of the new antidepressant will occur immediately after V1. To maximize acceptability by referring psychiatrists, dosage and co-prescriptions will be at the discretion of the psychiatrist in charge, but the assigned treatment will not be changed for 4 weeks (until V3).
* V2 (7 days after the beginning of the new antidepressant - 'early response visit'):
o Similar to V1.
* V3 (28 days after the beginning of the new antidepressant - 'conventional response visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Blood samples
* V4 (6 months after the beginning of the new antidepressant - 'remission visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating.
* Structural (anatomical) MRI, ASL
* Blood samples
* V5 (one year after the beginning of the new antidepressant - 'functional remission visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
36 healthy volunteers without a history of neurologic or psychiatric disorder, matched for age, gender, and education will be included. They will perform V0-V2 (without MRI and blood sample at V2). Healthy volunteers will not receive any treatment as part of the research.
* V0 (inclusion visit): verification of inclusion and exclusion criteria, information, and consent.
* V1 (before randomization - baseline state):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Neuro-cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating. Part of the tests will be performed during the functional MRI session.
* Structural (anatomical) and functional MRI, ASL.
* Blood samples.
* Randomization and introduction of the new antidepressant will occur immediately after V1. To maximize acceptability by referring psychiatrists, dosage and co-prescriptions will be at the discretion of the psychiatrist in charge, but the assigned treatment will not be changed for 4 weeks (until V3).
* V2 (7 days after the beginning of the new antidepressant - 'early response visit'):
o Similar to V1.
* V3 (28 days after the beginning of the new antidepressant - 'conventional response visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Blood samples
* V4 (6 months after the beginning of the new antidepressant - 'remission visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
* Cognitive evaluation using a battery of tests to explore motivation, emotion processing, belief construction, and their updating.
* Structural (anatomical) MRI, ASL
* Blood samples
* V5 (one year after the beginning of the new antidepressant - 'functional remission visit'):
* Clinical evaluation using validated questionnaires for the severity of depression, quality of life, anhedonia, apathy, and cognitive dysfunction.
36 healthy volunteers without a history of neurologic or psychiatric disorder, matched for age, gender, and education will be included. They will perform V0-V2 (without MRI and blood sample at V2). Healthy volunteers will not receive any treatment as part of the research.
Conditions
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Major Depressive Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomization and introduction of the new antidepressant will occur immediately after V1. Patients will receive an antidepressant as monotherapy after randomization between two strategies: escitalopram and vortioxetine. To maximize acceptability by referring psychiatrists, dosage and co-prescriptions will be at the discretion of the psychiatrist in charge, but the allocated treatment will not be changed for 4 weeks (until V3).
After 4 weeks, the treatment can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
After 4 weeks, the treatment can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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escitalopram strategy
The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist.
Group Type
OTHER
escitalopram
Intervention Type
OTHER
Patients will receive an antidepressant strategy : escitalopram. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
vortioxetine strategy
The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist.
Group Type
OTHER
vortioxetine
Intervention Type
OTHER
Patients will receive an antidepressant strategy : vortioxetine. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the treatment strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
Interventions
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escitalopram
Patients will receive an antidepressant strategy : escitalopram. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
Intervention Type
OTHER
vortioxetine
Patients will receive an antidepressant strategy : vortioxetine. The strategy will not be modified for a period of 4 weeks. Dosage adjustment and co-prescriptions will be at the discretion of the refeering psychiatrist. After 4 weeks, the treatment strategy can be adapted by the refeering psychiatrist exactly as if the patient had not been included in the trial.
Intervention Type
OTHER
Eligibility Criteria
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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
\- Valid health care insurance
* 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 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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centre Hospitalier St Anne
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Groupe hospitalo-universitaire de Grenoble Alpes
La Tronche, Isère, France
Site Status
NOT_YET_RECRUITING
Centre hospitalier Universitaire de Lille
Lille, Nord, France
Site Status
NOT_YET_RECRUITING
Centre hospitalier Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Site Status
NOT_YET_RECRUITING
Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université
Paris, , France
Site Status
NOT_YET_RECRUITING
- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
Paris, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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Mircea Polosan
Role: primary
Renaud Jardri
Role: primary
Eric Fakra
Role: primary
Philippe Fossati
Role: primary
Fabien Vinckier
Role: primary
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D20-P059
Identifier Type: -
Identifier Source: org_study_id
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