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Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

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The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events, vital signs, ECGs and laboratory tests; secondary aims explore symptoms, body image, anxiety and weight (n=16).

Details

Single-group, open-label interventional study in adults (18–40 years) with DSM‑5 anorexia nervosa evaluating one 25 mg oral dose of psilocybin given with preparatory and integration psychotherapy; dosing session lasts approximately 4–6 hours.

Outcomes focus on safety and tolerability (AEs, vitals, ECG, labs) with exploratory efficacy measures for eating‑disorder symptoms, body image, anxiety, food‑related obsessions and rituals, and body weight over a one‑month follow‑up.

Topics:Eating Disorders

Registry

Registry linkNCT04661514