PMID- 37488291
OWN - NLM
STAT- MEDLINE
DCOM- 20230817
LR  - 20240229
IS  - 1546-170X (Electronic)
IS  - 1078-8956 (Print)
IS  - 1078-8956 (Linking)
VI  - 29
IP  - 8
DP  - 2023 Aug
TI  - Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label 
      feasibility study.
PG  - 1947-1953
LID - 10.1038/s41591-023-02455-9 [doi]
AB  - 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 .
CI  - (c) 2023. The Author(s).
FAU - Peck, Stephanie Knatz
AU  - Peck SK
AUID- ORCID: 0000-0001-9421-9158
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA. sknatz@health.ucsd.edu.
FAU - Shao, Samantha
AU  - Shao S
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
FAU - Gruen, Tessa
AU  - Gruen T
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
AD  - University of Michigan Medical School, Ann Arbor, MI, USA.
FAU - Yang, Kevin
AU  - Yang K
AUID- ORCID: 0000-0002-1451-258X
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
FAU - Babakanian, Alexandra
AU  - Babakanian A
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
FAU - Trim, Julie
AU  - Trim J
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
FAU - Finn, Daphna M
AU  - Finn DM
AUID- ORCID: 0000-0003-2572-7778
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA.
FAU - Kaye, Walter H
AU  - Kaye WH
AUID- ORCID: 0000-0002-4478-4906
AD  - Department of Psychiatry, Eating Disorder Treatment & Research Center, University 
      of California, San Diego, San Diego, CA, USA. wkaye@health.ucsd.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT04661514
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230724
PL  - United States
TA  - Nat Med
JT  - Nature medicine
JID - 9502015
RN  - 2RV7212BP0 (Psilocybin)
SB  - IM
CIN - Nat Med. 2023 Aug;29(8):1906-1907. PMID: 37488290
CIN - Nat Rev Drug Discov. 2023 Sep;22(9):697. PMID: 37532824
MH  - Adult
MH  - Humans
MH  - Female
MH  - *Psilocybin/adverse effects
MH  - *Anorexia Nervosa/drug therapy
MH  - Feasibility Studies
MH  - Body Mass Index
MH  - Treatment Outcome
PMC - PMC10427429
COIS- S.K.P. is a senior clinical consultant for Compass Pathways, the funder of the 
      study, and receives compensation for this role. Additionally, she is a 
      sub-investigator for an upcoming Compass-sponsored randomized trial evaluating 
      psilocybin for anorexia nervosa and is a lead therapist for this trial and other 
      Compass-sponsored trials. W.H.K. has served as a consultant and advisor for 
      Compass Pathways, the funder of this study, and has received compensation for 
      these roles. W.H.K. has also received financial support for this study and for an 
      upcoming randomized controlled trial evaluating psilocybin for anorexia nervosa, 
      which is sponsored by Compass Pathways. Additionally, he serves as site principal 
      investigator for the upcoming referenced trial. S.S., T.G., K.Y., A.B., J.T. and 
      D.F.M. report no competing interests.
EDAT- 2023/07/25 01:09
MHDA- 2023/08/17 06:43
PMCR- 2023/07/24
CRDT- 2023/07/24 23:29
PHST- 2022/10/27 00:00 [received]
PHST- 2023/06/09 00:00 [accepted]
PHST- 2023/08/17 06:43 [medline]
PHST- 2023/07/25 01:09 [pubmed]
PHST- 2023/07/24 23:29 [entrez]
PHST- 2023/07/24 00:00 [pmc-release]
AID - 10.1038/s41591-023-02455-9 [pii]
AID - 2455 [pii]
AID - 10.1038/s41591-023-02455-9 [doi]
PST - ppublish
SO  - Nat Med. 2023 Aug;29(8):1947-1953. doi: 10.1038/s41591-023-02455-9. Epub 2023 Jul 
      24.