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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 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

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 • NCT02061293
9%
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

COMP360 Psilocybin Therapy (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05481736 — Phase 2
Anorexia Nervosa Research Study Groups: 1 mg COMP360 Psilocybin, 25 mg COMP360 Psilocybin
Anorexia Nervosa Clinical Trial 2023: COMP360 Psilocybin Therapy Highlights & Side Effects. Trial Name: NCT05481736 — Phase 2
COMP360 Psilocybin Therapy (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05481736 — Phase 2
Anorexia Nervosa Patient Testimony for trial: Trial Name: NCT05481736 — Phase 2
~0 spots leftby Nov 2024