- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481736
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
December 11, 2023 updated by: COMPASS Pathways
Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study
Study Overview
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
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medical Director, MD
- Email: COMP401trial@compasspathways.com
Study Locations
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Dublin, Ireland
- Recruiting
- Tallaght University Hospital
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Contact:
- Annie Baker
- Email: psilocybin@crp.healthcare
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Principal Investigator:
- John Kelly, MD
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London, United Kingdom
- Recruiting
- Kings College London, Institute of Psychiatry, Psychology and Neurology
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Contact:
- Katie Rowlands
- Email: katie.rowlands@kcl.ac.uk
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Principal Investigator:
- Hubertus Himmerich
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California
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San Diego, California, United States, 92037
- Recruiting
- Altman Clinical and Translational Research Institute
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Contact:
- Jessie Kim
- Email: jbk005@health.ucsd.edu
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Contact:
- Alexandra Babakanian
- Email: alexandrambabakanian@gmail.com
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Principal Investigator:
- Walter Kaye, MD
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Maryland
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Baltimore, Maryland, United States, 21044
- Recruiting
- Sheppard Pratt Health System
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Principal Investigator:
- Scott Aaronson, MD
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Contact:
- Kimberly Swartz
- Email: IADTclinicaltrials@sheppardpratt.org
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Contact:
- Audrey Shoultz
- Email: IADTclinicaltrials@sheppardpratt.org
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New York
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New York, New York, United States, 10032
- Not yet recruiting
- New York State Psychiatric Institute
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Contact:
- Caroline Touzeau
- Email: caroline.touzeau@nyspi.columbia.edu
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Principal Investigator:
- Evelyn Attia
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Contact:
- Mae Winglass
- Email: mae.winglass@nyspi.columbia.edu
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Texas
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Austin, Texas, United States, 78712
- Recruiting
- Dell Medical School
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Principal Investigator:
- Julie Farrington, MD
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Contact:
- Julie Farrington, MD
- Email: psychclinicaltrials@austin.utexas.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 25 mg COMP360 Psilocybin
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COMP360 Psilocybin administered under supportive conditions
Other Names:
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Active Comparator: 1 mg COMP360 Psilocybin
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COMP360 Psilocybin administered under supportive conditions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the Eating Disorder Examination (EDE) global score
Time Frame: Week 4
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The EDE is a structured clinical interview (investigator rated) used to measure severity of the characteristic psychopathology of eating disorders
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Up to 12 weeks
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Proportion of patients with adverse events (AEs)
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Up to 12 weeks
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Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Week 4
|
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
|
Change from baseline in weight
Time Frame: Up to 12 weeks
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
July 28, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMP 401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
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Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
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Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
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Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
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The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
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Clinical Trials on Psilocybin
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Yale UniversityHeffter Research Institute; Ceruvia Lifesciences; CH TAC LLCCompleted
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University of Wisconsin, MadisonTRYP TherapeuticsWithdrawn
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Yale UniversityCeruvia LifesciencesCompleted
-
King's College LondonUniversity of CambridgeRecruitingAutism Spectrum DisorderUnited Kingdom
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Section for Affective Disorders; Northern Stockholm...Karolinska Institutet; Vastra Gotaland Region; Region Örebro County; Uppsala University...Recruiting
-
Yale UniversityHeffter Research InstituteActive, not recruitingMajor Depressive DisorderUnited States
-
University Health Network, TorontoCentre for Addiction and Mental HealthRecruitingDepression | Mood Disorders | Major Depressive Disorder | Treatment-Resistant DepressionCanada
-
Yale UniversityTerminated
-
Multidisciplinary Association for Psychedelic StudiesWithdrawnAnxiety | Stage IV MelanomaUnited States
-
University of Colorado, DenverNot yet recruitingAnhedonia | Major Depressive Disorder | Treatment Resistant DepressionUnited States