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 lab..., Data was collected via self-report behavioral assessments under the monitoring of a clinical research coordinator and via medical assessments conducted at the Altman Clinical Translational Reseach Institute by nurse practictioners and medical assistants under the supervision of the site PI physician. Data were manually entered into a database and/or imported from Qualtrics surveys (behavioral assessments). Scale and subscale scores were processed in Microsoft Excel. The research coordinator and site PI and Co-I oversaw this process. The final database was then sent to Phastar, the organization who coded and analyzed the data for all statistical analyses conducted and reported in the study. , Microsoft ExcelÂ