Ellen James, PhD, Director of Research and Development, Small Pharma, London, UK, shares the initial findings from a Phase I/IIa placebo-controlled, single ascending dose study of SPL026 with supportive therapy for the treatment of major depressive disorder (MDD). SPL026 is a short acting DMT-assisted psychedelic treatment given in combination with supportive therapy. It is thought to give near-immediate, long-lasting antidepressant effects, while the subjective psychedelic experience only lasts 20-30 minutes. The Phase I portion of the trial recruited 32 psychedelic-naïve, healthy volunteers who received intravenous SPL026 at one of four dose levels or placebo. All drug-related adverse events were mild and short lived, resolving on the day of dosing, and participant feedback suggested the psychedelic experience was well tolerated. Additionally, consistent dose related effects on the quality of the psychedelic experience were noted. Participants with greater drug exposure reported higher scores on the richness of their experience. These data have informed optimal dosing to be taken forward into the Phase IIa portion of the trial which will treat patients with moderate-severe MDD. This interview took place at the 35th European College of Neuropsychopharmacology (ECNP) Congress 2022 in Vienna, Austria.
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