This observational case-control study (n=60) aims to understand the brain mechanisms involved in belief updating about the future in patients with treatment-resistant depression (TRD) before and after starting ketamine treatment.
The study, sponsored by Assistance Publique – Hôpitaux de Paris, seeks to enrol 60 participants diagnosed with TRD, aged between 18 to 70 years. Participants must have major depressive disorder (MDD) according to DSM5 criteria, with a MADRS score of ≥20 and resistance to at least two different antidepressant treatments. Patients will undergo functional magnetic resonance imaging (fMRI) before or 24 hours after a single subanaesthetic ketamine infusion.
The main outcome measure will be the blood oxygenation level-dependent (BOLD) signal measured with fMRI. Secondary outcome measures include assessing belief updating on the behavioural level, clinical improvement measured by the MADRS scale, and prognostic expectancy rating of antidepressant efficacy.
The study is designed as an observational case-control model with a prospective time perspective. It aims to provide insights into the neurocognitive mechanisms of belief updating in depressed patients and how these mechanisms may contribute to clinical improvement following ketamine antidepressant treatment.
Trial Details
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