Clinical trial NCT05866575: Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation
Official title: Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the early changes (differences between V1 and V2) of the computational phenotype of depressed patients.
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
Secondary outcomes:
measure: Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the early changes (differences between V1 and V2) of the neuro-computational phenotype of depressed patients
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
measure: Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the initial (baseline state- V1) neuro-computational phenotype of depressed patients
timeFrame: Baseline state (before the start of antidepressant strategy), and V3 (after 28 days of antidepressant)
measure: Prediction of long-term remission (V4) based on the early changes (differences between V1 and V2) of the neuro-computationnal phenotype of depressed patients
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V4 (6 months after the start of antidepressant)
measure: Prediction functional remission (V5) based on the early changes (differences between V1 and V2) of the neuro-computationnal phenotype of depressed patients
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V5 (1 year after the start of antidepressant)
measure: Prediction of relapse at one year (V5) based on the computationnal phenotype of remitted patients at 6 months (V4).
timeFrame: V4 (6 months after the start of antidepressant), V5 (1 year after the start of antidepressant)
measure: Description of the motivational deficit of depressed patients at baseline (V1).
timeFrame: Baseline state (before the start of antidepressant strategy)
measure: Description of the neural correlates of motivation deficits of depressed patients at baseline (V1).
timeFrame: Baseline state (before the start of antidepressant strategy)
measure: Description of the evolution of motivation deficit of depressed patients after one week of antidepressant treatment
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
measure: Description of the evolution of the neural correlates of motivation deficits after one week of antidepressant treatment
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
measure: Description of the evolution of motivation deficit of depressed patients at 6 months
timeFrame: Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
measure: Description of the evolution of the structural neural correlates of depression after 6 months of treatment
timeFrame: Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
measure: Description of the evolution of the functional neural correlates of depression after 6 months of treatment
timeFrame: Baseline state (before the start of antidepressant strategy) V4 (6 months after the start of antidepressant)
measure: Construction of a bio-bank
timeFrame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant), V4 (6 months after the start of antidepressant)
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Groupe hospitalo-universitaire de Grenoble Alpes
state: Isère
city: Saint-Priest-en-Jarez
country: France
facility: Centre hospitalier Universitaire de Saint-Etienne
state: Loire
city: Lille
country: France
facility: Centre hospitalier Universitaire de Lille
state: Nord
city: Paris
country: France
facility: Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université
city: Paris
country: France
facility: - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
Study officials:
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