Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression

What are the efficacy and safety of psilocybin, 25 mg, with adjunct psychotherapy in treatment-resistant major depression (TRD)?In this randomized clinical trial including 144 adults with TRD, there were nonsignificant differences in the response rate on the Hamilton Rating Scale for Depression at 6 weeks (primary end point) for psilocybin, 25 mg; psilocybin, 5 mg; and nicotinamide. However, secondary outcomes showed clinically meaningful reductions in depressive symptoms for psilocybin, 25 mg vs comparators.Although the primary end point was negative, secondary outcomes suggest that psilocybin, 25 mg, with adjunct psychotherapy may exert clinically meaningful antidepressant effects in TRD.

Corresponding Author: Gerhard Gründer, Department of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J5, 68159 Mannheim, Germany (gerhard.gruender@zi-mannheim.de).

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