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Belief Updating in Treatment Resistant Depression

NCT05577247 · KETABELIEF · Assistance Publique - Hôpitaux de Paris

Recruiting
Status
Accepting participants
Not applicable
Phase
60
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Major depressive disorder (MDD) is characterized by a cognitive triad of negative beliefs about oneself, the future and the world. For example, depressed patients hold persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important role in the maintenance of depressive symptoms and potentially in treatment resistance. Indeed, one out of three patients with major depressive disorder does not respond to conventional, monoaminergic treatments, which has led to the concept of treatment resistant depression (TRD). It is unknown how the brain encodes the strong negative beliefs that are insensitive to positive disconfirming information in TRD patients, and how these neural underpinnings of maladaptive belief updating are altered by antidepressant treatment. The principal objective of this study is to gain insight into the brain mechanisms of belief updating about the future in TRD patients before and after starting ketamine treatment. The results of this study are expected to provide a better understanding of the neurocognitive mechanisms of belief-updating in depressed patients, and how these mechanisms contribute to clinical improvement following ketamine antidepressant treatment.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Blood oxygenation level dependant (BOLD) signal

    Measured over 7 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: Demographic criteria: * Age: 18 to 70 years * Male et female Diagnostic criteria, severity and clinical course: * Major depressive disorder (MDD) according to the DSM5 criteria * MADRS≥20, * Treatment resistant depression (TRD) defined by failure to respond to at least two trials of different antidepressant treatments * affiliation of a social security regime Treatments/strategies/procedures: o At the start of new antidepressant treatment involving glutamate receptor modulators. Exclusion criteria: Criteria relating to associated pathologies carrying specific risks: * Mental disorder other than MDD: personality disorder type borderline, schizophrenia * Inability to understand the task instructions and to perform the behavioral task * Mini Mental Score (MMS) ≤ 25 * Antidepressant treatment involving dopaminergic agonists, and Monoamine oxidase inhibitors (MAOI) * Neurological comorbidities : epilepsy, brain tumor, non-corrected visual and/or auditory deficit Criteria associated with contraindications/procedures/interventions added by the research: o Contra-indications for an MRI exam (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, metallic contraceptive device, claustrophobia, unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)) Criteria relating to vulnerable populations: * Pregnancy * Patient on AME (state medical aid) * Patient under guardianship, curators or legal protection

Where

1 study site

FacilityCityRegionCountry
GH Pitié SalpêtrièreParis—France

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05577247 on ClinicalTrials.gov →

Last updated in the registry 2026-04-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from Assistance Publique - Hôpitaux de Paris →