Efficacy and Safety of COMP360 Psilocybin Therapy... — Clinical Trial Details

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.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

25 mg COMP360

Interventions

1 mg COMP360

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators