Psilocybin therapy for females with anorexia nervosa: A phase 1, open label, feasibility study

Anorexia nervosa (AN) is a deadly illness with no proven treatments to reverse core symptoms and no FDA-approved medications. Novel treatments are urgently needed to improve clinical outcomes. In this open-label feasibility study, 10 adult female participants (m BMI 19.7 kg/m²; SD 3.7) who met DSM 5 criteria for AN or pAN (partial remission) were recruited to a study conducted at an academic clinical research institute. Participants received a single 25mg dose of synthetic psilocybin combined with psychological support. The primary aim was to assess safety, tolerability, and feasibility at post-treatment via incidences and occurrences of adverse events (AEs) and clinically significant changes in: ECG, laboratory tests, vital signs and suicidality. There were no clinically significant changes in ECG, vital signs, or suicidality. Two participants developed asymptomatic hypoglycemia at post-treatment, which resolved within 24 hours. There were no other clinically significant changes in laboratory values. All AEs were mild and transient in nature. Participants' qualitative perceptions suggest that the treatment was acceptable for most participants. Results suggest that psilocybin therapy is safe, tolerable, and acceptable for female AN, a promising finding given physiological dangers and problems with treatment engagement.

ClinicalTrials.gov Identifier: NCT04661514