Your session is about to expire
← Back to Search
Psychedelic
Psilocybin Therapy for Anorexia Nervosa
Phase 2
Recruiting
Research Sponsored by COMPASS Pathways
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This trial suggests that psilocybin therapy may be an effective treatment for anorexia nervosa.
Who is the study for?
Adults aged 18+ with Anorexia Nervosa (AN), either restrictive or binge-purging type, who have tried at least one treatment in the past 3 years. Participants must be medically stable, not currently abusing substances, and have a BMI between 15-20 kg/m2. They should not have serious psychiatric conditions like bipolar disorder or schizophrenia, nor a history of substance use disorders within the last year.Check my eligibility
What is being tested?
The trial is testing COMP360 Psilocybin therapy's effectiveness and safety for treating Anorexia Nervosa. It's an early-stage study to see how well it works and what risks are involved when given to people with AN under controlled conditions.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, psilocybin can commonly cause headache, nausea, increased heart rate and blood pressure, altered sensory experiences and mood changes. Rarely it may provoke anxiety or distressing hallucinations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the Eating Disorder Examination (EDE) global score
Secondary outcome measures
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Change from baseline in weight
Safety
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 25 mg COMP360 PsilocybinExperimental Treatment1 Intervention
25 mg COMP360 Psilocybin
Group II: 1 mg COMP360 PsilocybinActive Control1 Intervention
1 mg COMP360 Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
COMPASS PathwaysLead Sponsor
14 Previous Clinical Trials
1,498 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
16 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 15 and 20, and I may need special approval if it's between 16 and 18.5.I haven't used psychedelics like LSD or psilocybin in the last year.I do not have a history of serious psychiatric conditions like bipolar or schizophrenia.I have stopped taking certain medications for two weeks, and for Prozac, four weeks before starting the trial.My overall health is stable according to recent medical exams.You have a confirmed diagnosis of anorexia nervosa, either restrictive or binge-purging type, based on medical records, assessments, and tests.I am 18 years old or older.I have tried at least one treatment for my condition in the last 3 years.I have stopped taking certain medications for two weeks, and for Prozac, four weeks before starting the trial.I am 18 years old or older.My overall health is stable as confirmed by recent medical exams.You have struggled with an eating disorder that is similar to anorexia nervosa for at least 3 years before the screening.I have tried at least one treatment for my condition in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: 1 mg COMP360 Psilocybin
- Group 2: 25 mg COMP360 Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anorexia Nervosa Patient Testimony for trial: Trial Name: NCT05481736 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Psilocybin pose any significant risks to those taking it?
"Due to the lack of evidence for psilocybin's efficacy, Power gave it a score of 2 on its safety scale. This is because this particular trial is in Phase 2 and there are some reports that point toward its safety."
Answered by AI
Are there any more vacancies available for participants in this research?
"As per information published on clinicaltrials.gov, this investigation is actively seeking participants; it was initially announced on October 12th 2022 and revised subsequently on the 21st of that same month."
Answered by AI
What is the current headcount of participants in this research program?
"Affirmative, the data provided on clinicaltrials.gov confirms that this medical trial launched on October 12th 2022 and is currently recruiting participants. To complete the study, 60 individuals must be recruited from 3 separate locations."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
Other
California
New York
How old are they?
18 - 65
What site did they apply to?
Other
Altman Clinical and Translational Research Institute
Sheppard Pratt Health System
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
Why did patients apply to this trial?
I have been in many treatment centers and have tried many methods in my recovery. I am able to get to a stable place, but always end up relapsing.
PatientReceived no prior treatments
I’ve tried various treatments and read books and listened to podcasts and….nothing has stuck so far. I want to recover and want to try a new path to freedom…for me and for my 2 girls.
PatientReceived 1 prior treatment
I have been struggling for almost a decade, have been to multiple different treatment centers and tried every type of therapy. I really want help, but nothing seems to be effective for me.
PatientReceived no prior treatments
I have been trying to recover from anorexia nervosa since I was 16, despite many years of therapy, work with a dietician, meds, and multiple intensive outpatient programs. I have not been able to reach recovery past pseudo-recovery. I started becoming very aware of my weight when I was 6 years old, where I would cry when I tried on bathing suits or get weighed at the pediatrician. I am now 26 and am still unable to get past the fear of weight gain.
PatientReceived no prior treatments
I am 24 years old from Ireland and have been in and out of in patient treatment for the past 7 years. I am desperate and scared I will never ever recover and yet I can’t seem to use that fear to get better and change either and I am terrified my brain will never Rewire and I will have these thoughts and behaviours and fears forever. I would do anything to enter this trial, especially if it’s possible in Ireland but I would also travel/move if necessary.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I was recently neuropsych tested and have been diagnosed with chronic PTSD, OCD, and MDD. Does this effect eligibility for the trial?
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger