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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 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
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 Vital signs Asymptomatic Bulimia nervosa
Citations 150
Registration NCT04661514
Key points 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 .

Comparable studies

Other non-randomized and open-label trials on psilocybin, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Patients with moderate-to-severe, unipolar, treatment-resistant major depression 2016 Open-label feasibility trial n = 12
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction Psychiatrically healthy nicotine-dependent smokers 2014 Open-label pilot study n = 15
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder Subjects with obsessive-compulsive disorder (OCD) 2006 Controlled clinical trial

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