Actively Recruiting
How the Brain Encodes Beliefs: A Functional Magnetic Resonance Imaging Study of the Belief Updating in Treatment Resistant Depression.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating how the brain processes belief updating in patients with treatment resistant depression (TRD), a condition where negative beliefs about oneself, the future, and the world persist despite evidence to the contrary. This study aims to understand the brain mechanisms behind this difficulty in changing negative beliefs, especially in patients who do not respond to typical antidepressant treatments. The focus is on how ketamine treatment may affect these brain processes and belief updating compared to other antidepressants. The study involves 120 patients with TRD who will be tested twice: once before and once 24 hours after starting a new antidepressant treatment. Sixty patients will receive a ketamine infusion and undergo functional magnetic resonance imaging (fMRI) to observe brain activity related to belief updating. The other 60 patients will be assessed behaviorally after starting monoaminergic antidepressants in their routine clinical care. Participants will complete a cognitive task presenting 40 adverse life events and rate the events on various emotional and personal factors. Throughout the study, clinical measures including depression severity and treatment resistance will be collected by psychiatrists. The primary outcome is the brain's oxygenation signal (BOLD) measured by fMRI, focusing on changes before and after treatment. Secondary outcomes include behavioral measures of belief updating and depression rating scales. The study is observational, conducted in a natural care setting, with assessments occurring within seven days of the first antidepressant dose.
CONDITIONS
Brief Title
Belief Updating in Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Male or female
- Diagnosed with major depressive disorder (MDD) according to DSM5 criteria
- Depression severity with MADRS score of 20 or higher
- Treatment resistant depression defined by failure to respond to at least two different antidepressant treatments
- Affiliated with a social security regime
- Starting a new antidepressant treatment involving glutamate receptor modulators
You will not qualify if you...
- Diagnosis of other mental disorders such as borderline personality disorder or schizophrenia
- Unable to understand instructions or complete the behavioral task
- Mini Mental Score (MMS) of 25 or below
- Current treatment with dopaminergic agonists or monoamine oxidase inhibitors (MAOI)
- Neurological conditions like epilepsy, brain tumor, or uncorrected visual/auditory deficits
- Contraindications for MRI such as metallic implants, pacemaker, brain vascular malformation, or claustrophobia
- Pregnancy
- Receiving state medical aid (AME)
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants complete cognitive belief updating tasks and rate life events to assess belief updating biases before and after antidepressant treatment.
2 visits (before and 24 hours after first antidepressant dose)
Duration - Up to 7 days
Participants receive antidepressant treatment as part of their routine medical care and clinical measures are collected to monitor treatment resistance and global clinical improvement.
Trial Site Locations
Total: 1 location
1
GH Pitié Salpêtrière
Paris, France
Actively Recruiting
Research Team
P
Philippe FOSSATI, PUPH
L
Liane Schmidt, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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