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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481736
• Other study ID #: COMP 401
• Status: Recruiting
• Phase: Phase 2
• Start date: October 12, 2022
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: COMPASS Pathways
• Contact: Medical Director, MD
• Email: COMP401trial[@]compasspathways.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Drug:
• Psilocybin
COMP360 Psilocybin administered under supportive conditions

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
COMPASS Pathways

Countries where clinical trial is conducted

United States,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety	Proportion of patients with adverse events (AEs)	Up to 12 weeks
Secondary	Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	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	Week 4
Secondary	Change from baseline in weight		Up to 12 weeks