- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05866575
Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation (STRATIDEP)
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabien Vinckier
- Phone Number: 0033683714083
- Email: f.vinckier@ghu-paris.fr
Study Contact Backup
- Name: Claire Jaffré
- Phone Number: 0033650557373
- Email: claire.jaffre@yahoo.fr
Study Locations
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Paris, France, 75013
- Groupe hospitalo-universitaire Assistance Publique, hôpital Pitié Salpêtrière - Hôpitaux de Paris Sorbonne Université
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Contact:
- Philippe Fossati
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Paris, France, 75014
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
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Contact:
- Fabien Vinckier
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Isère
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La Tronche, Isère, France, 38700
- Groupe hospitalo-universitaire de Grenoble Alpes
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Contact:
- Mircea Polosan
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Loire
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Saint-Priest-en-Jarez, Loire, France, 42270
- Centre Hospitalier Universitaire de Saint-Etienne
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Contact:
- Eric Fakra
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Nord
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Lille, Nord, France, 59000
- Centre Hospitalier Universitaire de Lille
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Contact:
- Renaud Jardri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
|
The therapeutic response will be measured with the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10- item scale widely used in depression research to assess the severity of depression. Response will be defined by a score divided by 2 compared to baseline MADRS score, while remission will be defined by a score < 7 (symptom absent) 28 days after the initiation of the antidepressant strategy. The "computational phenotype" is the outcome of the computationnal analysis of behavior. It is expressed in abstract unit. The change in computationnal phenotype between V1 and V2 will be entered in logistic regression aiming to predict clinical response at 28 days, measured with the MADRS score. |
Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
|
Same than outcome 1 but using brain imaging on top of behavior (neurocomputational modeling) to predict clinical response.
|
Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant) and V3 (after 28 days of antidepressant)
|
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
Time Frame: Baseline state (before the start of antidepressant strategy), and V3 (after 28 days of antidepressant)
|
Same than Outcome 2 but using only V1 instead of the change between V1 and V2 to predict clinical response.
|
Baseline state (before the start of antidepressant strategy), and V3 (after 28 days of antidepressant)
|
Prediction of long-term remission (V4) based on the early changes (differences between V1 and V2) of the neuro-computationnal phenotype of depressed patients
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V4 (6 months after the start of antidepressant)
|
Same than Outcome 2 but to predict clinical remission at V4 instead of clinical response at V3.
|
Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V4 (6 months after the start of antidepressant)
|
Prediction functional remission (V5) based on the early changes (differences between V1 and V2) of the neuro-computationnal phenotype of depressed patients
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V5 (1 year after the start of antidepressant)
|
Same than Outcome 2 but to predict functional remission at V5 instead of clinical response at V3.
|
Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant), V5 (1 year after the start of antidepressant)
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Prediction of relapse at one year (V5) based on the computationnal phenotype of remitted patients at 6 months (V4).
Time Frame: V4 (6 months after the start of antidepressant), V5 (1 year after the start of antidepressant)
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Same than Outcome 1 but using computational phenotype at V4 to predict predict functional remission at V5.
|
V4 (6 months after the start of antidepressant), V5 (1 year after the start of antidepressant)
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Description of the motivational deficit of depressed patients at baseline (V1).
Time Frame: Baseline state (before the start of antidepressant strategy)
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Comparison of the computational phenotype of patients with depression and healthy volunteers at V1.
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Baseline state (before the start of antidepressant strategy)
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Description of the neural correlates of motivation deficits of depressed patients at baseline (V1).
Time Frame: Baseline state (before the start of antidepressant strategy)
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Comparison of the brain functional statistical maps of patient with depression and healthy volunteers at V1.
|
Baseline state (before the start of antidepressant strategy)
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Description of the evolution of motivation deficit of depressed patients after one week of antidepressant treatment
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
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Comparison of the computational phenotype of patients with depression at V1 and V2.
|
Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
|
Description of the evolution of the neural correlates of motivation deficits after one week of antidepressant treatment
Time Frame: Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
|
Comparison of the brain functional statistical maps of patient with depression at V1 and V2.
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Baseline state (before the start of antidepressant strategy), V2 (after 7 days of antidepressant)
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Description of the evolution of motivation deficit of depressed patients at 6 months
Time Frame: Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
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Comparison of the computational phenotype of patients with depression at V1 and V4.
|
Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
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Description of the evolution of the structural neural correlates of depression after 6 months of treatment
Time Frame: Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
|
Comparison of the structural brain imaging of patients with depression at V1 and V4.
|
Baseline state (before the start of antidepressant strategy), V4 (6 months after the start of antidepressant)
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Description of the evolution of the functional neural correlates of depression after 6 months of treatment
Time Frame: Baseline state (before the start of antidepressant strategy) V4 (6 months after the start of antidepressant)
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Comparison of the function brain imaging (ASL) of patients with depression at V1 and V4.
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Baseline state (before the start of antidepressant strategy) V4 (6 months after the start of antidepressant)
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Construction of a bio-bank
Time Frame: 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)
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Serum tubes will be drowned along the study (V1, V2, V3 and V4 for patients - V1 for healthy volunteers) prepared and stored.
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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)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Selective Serotonin Reuptake Inhibitors
- Vortioxetine
- Escitalopram
Other Study ID Numbers
- D20-P059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The data obtained from medical visits (clinical informations, biological assessments, cognitive data) and brain MRIs will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed. These can be used later for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes.
In case of transfer of the anonymized database resulting from this research abroad (outside the EU), the sponsor undertakes to ensure a level of security equivalent to French or European Union law.
IPD Sharing Time Frame
IPD Sharing Access Criteria
The data can be used for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes.
In case of transfer of the anonymized database resulting from this research abroad (outside the EU), the sponsor undertakes to ensure a level of security equivalent to French or European Union law.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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