What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common side effects of treatments for Anorexia Nervosa that are similar to COMP360 Psilocybin therapy (serotonin receptor agonists, particularly 5-HT2A) include transient anxiety, nausea, dizziness, headaches, altered sensory perception, mood swings, and, in rare cases, severe psychological effects such as paranoia or psychosis. These side effects are generally short-lived and resolve within hours. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Anorexia Nervosa. Treatments generally focus on nutritional rehabilitation and psychotherapy. While COMP360 Psilocybin therapy, a serotonin receptor agonist targeting the 5-HT2A receptor, is being studied, no similar drugs have been approved for Anorexia Nervosa. Current pharmacological approaches often involve off-label use of medications aimed at comorbid conditions such as depression or anxiety.

What other types of research exist?

Promising novel alternatives to COMP360 Psilocybin therapy for Anorexia Nervosa patients include: 1) Olanzapine, an atypical antipsychotic that has shown significant weight restoration in clinical studies. 2) Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), which has been used in combination with family therapy. 3) Emerging therapies such as Lisdexamfetamine, which has shown efficacy in treating binge-eating disorder and may have potential for Anorexia Nervosa. 4) Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT) as psychological interventions with strong evidence for effectiveness.

← Back to Search

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

No Placebo-Only Group

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

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~530

Do I qualify?Apply below to find out

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.