This randomised, quadruple-blind, placebo-controlled Phase III trial (n=60) will study the early effects of ketamine compared to placebo as an adjunctive therapy with venlafaxine in inpatients with severe unipolar major depressive disorder (MDD).
Participants will receive three doses of intravenous ketamine (35mg/70kg) or a placebo, alongside standard venlafaxine treatment over a week.
The study, sponsored by Assistance Publique – Hôpitaux de Paris, aims to evaluate the rapid efficacy of ketamine in reducing depressive symptoms, as measured by the Hamilton Depression Rating Scale (HDRS). It will also assess biomarkers, synaptic density variations via PET-MRI, and the correlation between ketamine’s efficacy and synaptogenesis.
The trial will take place across three locations in France and is expected to begin in September 2024, with completion anticipated by April 2026.
Trial Details
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