Actively Recruiting

Age: 18Years - 70Years
All Genders
ID05577247

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

On this page

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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