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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05481736
Recruitment Status : Recruiting
First Posted : August 1, 2022
Last Update Posted : December 12, 2023
Information provided by (Responsible Party):
COMPASS Pathways

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

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Psilocybin Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
Actual Study Start Date : October 12, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: 25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360

Active Comparator: 1 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin
Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360

Primary Outcome Measures :
  1. Change from baseline in the Eating Disorder Examination (EDE) global score [ Time Frame: Week 4 ]
    The EDE is a structured clinical interview (investigator rated) used to measure severity of the characteristic psychopathology of eating disorders

Secondary Outcome Measures :
  1. Safety [ Time Frame: Up to 12 weeks ]
    Proportion of patients with adverse events (AEs)

  2. Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Week 4 ]
    The Y-BOCS self-rated version consists of a 10 item measure with a total score ranging from 0 to 40, with higher scores indicating increased severity of symptoms

  3. Change from baseline in weight [ Time Frame: Up to 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05481736

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Contact: Medical Director, MD

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United States, California
Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92037
Contact: Jessie Kim   
Contact: Alexandra Babakanian   
Principal Investigator: Walter Kaye, MD         
United States, Maryland
Sheppard Pratt Health System Recruiting
Baltimore, Maryland, United States, 21044
Contact: Kimberly Swartz   
Contact: Audrey Shoultz   
Principal Investigator: Scott Aaronson, MD         
United States, New York
New York State Psychiatric Institute Not yet recruiting
New York, New York, United States, 10032
Contact: Caroline Touzeau   
Contact: Mae Winglass   
Principal Investigator: Evelyn Attia         
United States, Texas
Dell Medical School Recruiting
Austin, Texas, United States, 78712
Contact: Julie Farrington, MD   
Principal Investigator: Julie Farrington, MD         
Tallaght University Hospital Recruiting
Dublin, Ireland
Contact: Annie Baker   
Principal Investigator: John Kelly, MD         
United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology Recruiting
London, United Kingdom
Contact: Katie Rowlands   
Principal Investigator: Hubertus Himmerich         
Sponsors and Collaborators
COMPASS Pathways
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Responsible Party: COMPASS Pathways Identifier: NCT05481736    
Other Study ID Numbers: COMP 401
First Posted: August 1, 2022    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs