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

NCT05481736 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: COMP 401
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Eating Disorder Examination (EDE) global score

  The EDE is a structured clinical interview (investigator rated) used to measure severity of the characteristic psychopathology of eating disorders

  Week 4

Secondary Outcomes (3)

• Safety

  Up to 12 weeks

• Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Week 4

• Change from baseline in weight

  Up to 12 weeks

Study Arms (2)

25 mg COMP360 Psilocybin

EXPERIMENTAL

25 mg COMP360 Psilocybin

Drug: Psilocybin

1 mg COMP360 Psilocybin

ACTIVE COMPARATOR

1 mg COMP360 Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

COMP360 Psilocybin administered under supportive conditions

Also known as: COMP360

1 mg COMP360 Psilocybin; 25 mg COMP360 Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any sex and aged 18 years or above at screening.
• 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.
• 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.
• Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
• 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.
• Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
• Have at least one documented prior attempt at treatment in the past 3 years.

You may not qualify if:

• 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).
• Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
• Borderline personality disorder as demonstrated by medical history, the MINI Plus - BPD and clinical judgment.
• 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.
• 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.
• Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
• Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.

Sponsors & Collaborators

• COMPASS Pathways: lead

Study Sites (5)

Altman Clinical and Translational Research Institute

San Diego, California, 92037, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21044, United States

Location

Dell Medical School

Austin, Texas, 78712, United States

Location

Tallaght University Hospital

Dublin, Ireland

Location

Kings College London, Institute of Psychiatry, Psychology and Neurology

London, United Kingdom

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: October 12, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

IE (1); US (3); GB (1)