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Psychedelic
Psilocybin Therapy for Anorexia Nervosa
Phase 2
Waitlist Available
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
Summary
This trial is testing a treatment using psilocybin, a substance from certain mushrooms, to help people with anorexia nervosa. The treatment aims to change brain function to improve mental health, especially for those who haven't responded well to other treatments. Psilocybin is a naturally occurring psychedelic that has shown promise in treating various psychiatric disorders, including mood and substance use disorders.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the Eating Disorder Examination (EDE) global score
Secondary study objectives
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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
~750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Anorexia Nervosa include psychotherapy, nutritional rehabilitation, and pharmacotherapy. Psychotherapy, such as Cognitive Behavioral Therapy (CBT), aims to address distorted thoughts and behaviors related to food and body image.
Nutritional rehabilitation focuses on restoring healthy eating patterns and weight. Pharmacotherapy often involves antidepressants like SSRIs, which increase serotonin levels to improve mood and reduce anxiety.
Treatments similar to COMP360 Psilocybin therapy, which acts as a serotonin receptor agonist (particularly 5-HT2A), are being studied for their potential to alter perception and cognition, potentially reducing obsessive thoughts about weight and food. This matters for Anorexia Nervosa patients as it may offer a novel approach to addressing the underlying psychological components of the disorder, potentially improving treatment outcomes.
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
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