Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study
Samantha Shao, Tessa Gruen, Alexandra Babakanian, Julie Trim, Stéphanie Knatz Peck, Kevin H. Yang, Daphna M. Finn, Walter H. Kaye
Nature Medicine July 24, 2023 DOI: 10.1038/s41591-023-02455-9 via OpenAlex
Summary
AI-generated from the abstractA single 25-mg dose of synthetic psilocybin combined with psychological support was safe, tolerable, and acceptable for 10 adult women with anorexia nervosa or partial remission. No clinically significant changes occurred in electrocardiogram, vital signs, or suicidality. Two participants developed asymptomatic hypoglycemia that resolved within 24 hours. All adverse events were mild and transient. The findings suggest psilocybin therapy may be a promising treatment for female anorexia nervosa, a condition with no FDA-approved medications and high physiological risks.
Study at a glance
| Characteristics | Open-label feasibility study Qualitative Peer reviewed |
|---|---|
| Sample size | 10 |
| Population | Adult female participants with anorexia nervosa or partial remission |
| Intervention | Psilocybin |
| Dose | 25 mg |
| Topics | Psilocybin |
| Keywords | Eating disorders Tolerability Anorexia nervosa Adverse effect |
| Citations | 150 |
| Registration | NCT04661514 |
| Key finding | Psilocybin therapy was safe, tolerable, and acceptable for female anorexia nervosa, with no clinically significant changes in ECG, vital signs, or suicidality and only mild, transient adverse events. |
Abstract
Abstract Anorexia nervosa (AN) is a deadly illness with no proven treatments to reverse core symptoms and no medications approved by the US Food and Drug Administration. Novel treatments are urgently needed to improve clinical outcomes. In this open-label feasibility study, 10 adult female participants (mean body mass index 19.7 kg m − 2 ; s.d. 3.7) who met Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (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 25-mg dose of synthetic psilocybin in conjunction with psychological support. The primary aim was to assess safety, tolerability and feasibility at post-treatment by incidences and occurrences of adverse events (AEs) and clinically significant changes in electrocardiogram (ECG), laboratory tests, vital signs and suicidality. No clinically significant changes were observed in ECG, vital signs or suicidality. Two participants developed asymptomatic hypoglycemia at post-treatment, which resolved within 24 h. No other clinically significant changes were observed 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, which is a promising finding given physiological dangers and problems with treatment engagement. ClinicalTrials.gov identifier NCT04661514 .