NCT05577247 Belief Updating in Treatment Resistant Depression
| NCT ID | NCT05577247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Treatment Resistant Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2026-12-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-05-13 with a primary completion date of 2026-12-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05577247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05577247 currently recruiting?
Yes, NCT05577247 is actively recruiting participants. Contact the research team at philippe.fossati@aphp.fr for enrollment information.
Where is the NCT05577247 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05577247 clinical trial?
NCT05577247 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 60 participants.
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