Recruiting

Belief Updating in Treatment Resistant Depression

ClinicalTrials.gov IDNCT05577247

PhaseNot Applicable

Enrollment60

SponsorAssistance Publique - Hôpitaux de Paris

Age18 Years

SexALL

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Conditions studied

Treatment Resistant Depression

About this study

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.

Interventions

Other: functional magnetic resonance imaging — Patients treated with ketamine antidepressants will be tested with fMRI before or 24h after a single ketamine infusion administered in the clinical setting.

Primary outcomes

Blood oxygenation level dependant (BOLD) signal (7 days)

Eligibility information

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

Study locations

GH Pitié Salpêtrière, Paris, France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.