Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Walter Kaye, MD

Description

Summary

Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study

Details

This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support in participants with Anorexia Nervosa

Keywords

Anorexia Nervosa Anorexia Psilocybin

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Any sex and aged 18 years or above at screening.
  2. Meeting criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessment, BMI, and documented completion of MINI 7.0.2 and EDE at screening.
  3. Have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline.
  4. Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
  5. BMI ≥15 kg/m2 and ≤20 kg/m2. For participants with a BMI <16 kg/m2 and >18.5 kg/m2 at screening, approval from the Medical Monitor will be required. Any participant with a BMI >18.5 kg/m2 must meet all of the criteria for AN except that, despite significant weight loss, the individual's weight is within or above the normal range.
  6. Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
  7. Have at least one documented prior attempt at treatment in the past 3 years.

You CAN'T join if...

  1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (MINI 7.0.2).
  2. Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
  3. Borderline personality disorder as demonstrated by medical history, the MINI Plus - BPD and clinical judgment.
  4. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview.
  5. Current (within last year) alcohol or substance use disorder as informed by the DSM-5 assessed via the MINI 7.0.2, and urine toxicology at screening.
  6. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
  7. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.

Locations

  • Altman Clinical and Translational Research Institute not yet accepting patients
    San Diego California 92037 United States
  • Sheppard Pratt Health System accepting new patients
    Baltimore Maryland 21044 United States

Lead Scientist at UCSD

  • Walter Kaye, MD
    Biography Dr. Kaye attended Ohio State Medical School, trained in neurology at the University of Southern California, trained in psychiatry at the University of California, Los Angeles, did research for 7 years on eating disorders at the National Institute of Mental Health, and was on the faculty of the University of Pittsburgh for 20 years until joining UCSD.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
COMPASS Pathways
ID
NCT05481736
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated