Clinical trial NCT05481736: Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
Official title: Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the Eating Disorder Examination (EDE) global score
timeFrame: Week 4
Secondary outcomes:
measure: Safety
timeFrame: Up to 12 weeks
measure: Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Week 4
measure: Change from baseline in weight
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Austin
country: United States
facility: Dell Medical School
state: Texas
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: London
country: United Kingdom
facility: Kings College London, Institute of Psychiatry, Psychology and Neurology
Study officials:
References: