drugset / Trial / NCT04661514
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
NaSingle-groupOpen-labelTreatment
Summary
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 (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.
Timeline
- Start
- 2021-05-01
- Primary completion
- 2022-03-10
- Completion
- 2022-06-10
Publications
- Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin Therapy for Females With Anorexia Nervosa: A Phase 1, Open-Label Feasibility Study. Focus (Am Psychiatr Publ). 2024 Jul;22(3):381-387. doi: 10.1176/appi.focus.24022013. Epub 2024 Jun 28.
- Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med. 2023 Aug;29(8):1947-1953. doi: 10.1038/s41591-023-02455-9. Epub 2023 Jul 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 25 mg | Oral |