Clinical TrialEating DisordersPsilocybinPsilocybinCompleted

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

Randomised, parallel-group Phase II study (n=32 actual) comparing COMP360 psilocybin 25 mg versus 1 mg with psychological support in adults with anorexia nervosa to evaluate efficacy and safety.

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Target Enrollment
32 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, parallel-group proof-of-concept trial evaluates COMP360 psilocybin (25 mg vs 1 mg) administered with psychological support in adults meeting DSM-5 criteria for anorexia nervosa.

Primary purpose is treatment; outcomes include clinical-effectiveness measures and safety assessments. Sites include centres in the United States, Ireland and the United Kingdom.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

25 mg COMP360

experimental

25 mg COMP360 Psilocybin

Interventions

  • Psilocybin25 mg
    via Oral• single dose

    COMP360 25 mg

1 mg COMP360

active comparator

1 mg COMP360 Psilocybin (active comparator)

Interventions

  • Psilocybin1 mg
    via Oral• single dose

    COMP360 1 mg (low-dose comparator)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Any sex and aged 18 years or above at screening.
  • 2. Meeting criteria for AN (restrictive or binge-purging type) according to 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 at least two weeks prior to baseline (fluoxetine requires immediate cessation at screening visit 1a and at least four weeks washout prior to baseline).
  • 4. History of disordered eating of at least 3 years prior to screening, consistent with AN.
  • 5. BMI ≥15 kg/m2 and ≤20 kg/m2. For participants with BMI <16 kg/m2 and >18.5 kg/m2 at screening, Medical Monitor approval required. Any participant with BMI >18.5 kg/m2 must meet all other AN criteria despite weight within/above normal range.
  • 6. Medically stable at screening as determined by clinical interview, labs, vitals, ECG, and history.
  • 7. At least one documented prior treatment attempt in the past 3 years.

Exclusion Criteria

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

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment32 participants
  • Timeline
    Start: 2022-08-01
    End: 2023-12-01
  • Compounds
    PsilocybinPsilocybin
  • Topic
    Eating Disorders

Study Team

Sponsors & Collaborators

Locations

Altman Clinical and Translational Research Institute — San Diego, California, United States
Sheppard Pratt Health System — Baltimore, Maryland, United States
Dell Medical School — Austin, Texas, United States
Tallaght University Hospital — Dublin, Ireland
Kings College London, Institute of Psychiatry, Psychology and Neurology — London, United Kingdom

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