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Study on the Effects of Psilocybin for Young Adults with Anorexia Nervosa

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Anorexia Nervosa, a serious eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading to restricted food intake and excessive weight loss. The treatment being tested is a capsule containing a dry extract from Psilocybe cubensis, a type of mushroom, with the active ingredient extracted using methanol. This treatment is referred to by the code name PEX010.

The purpose of the study is to evaluate the safety and tolerability of two doses of psilocybin (25 mg each), given one month apart, in young adults aged 16 to 35 years who have Anorexia Nervosa. The treatment will be administered with psychological support and compared to the standard care, known as Treatment as Usual (TAU). Participants will receive the treatment orally in capsule form.

Throughout the study, researchers will monitor for any adverse events, which are any unwanted effects that may occur during the trial. The study will also look at changes in anxiety, life satisfaction, and other psychological factors, as well as improvements in weight and symptoms of Anorexia Nervosa. The goal is to see if the treatment can help achieve and maintain weight restoration and psychological well-being, while reducing symptoms of the disorder.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of anorexia nervosa and ensuring the participant is between 16 and 35 years old.
The assessment also checks for a stable connection with an outpatient psychiatric unit and a BMI (Body Mass Index) greater than 16. A history of at least one period of remission with a minimum BMI of 17 followed by a relapse is required.
Step 2
First dose administration
The first dose of psilocybin is administered orally in the form of a capsule. The dosage is 25 mg.
This administration is accompanied by psychological support to ensure safety and comfort during the experience.
Step 3
Monitoring period
After the first dose, a monitoring period follows to observe any adverse events (unwanted effects) or serious adverse events.
Participants are evaluated for changes in anxiety, health, relationships, life satisfaction, emotions, harmony in life, self-compassion, personality, and anorexia nervosa symptom severity.
Step 4
Second dose administration
One month after the first dose, a second 25 mg dose of psilocybin is administered under similar conditions with psychological support.
The aim is to further assess the safety and tolerability of the treatment.
Step 5
Follow-up period
A follow-up period of six months is conducted to monitor the participant's progress.
The focus is on achieving and maintaining weight restoration and psychological well-being, with no significant symptoms of anorexia nervosa.
The occurrence of any relapse, defined as a return of symptoms, is also monitored during this period.

Who can join the trial?

5 criteria

Must have a diagnosis of Anorexia Nervosa as defined by DSM-5. (DSM-5 is a manual used by healthcare professionals to diagnose mental disorders.)
Must be between the ages of 16 and 35.
Must have ongoing stable contact with an outpatient psychiatric unit. (This means regularly visiting a mental health clinic without staying overnight.)
Must have a BMI greater than 16. (BMI, or Body Mass Index, is a measure of body fat based on height and weight.)
Must have experienced at least one period of remission with a minimum BMI of 17, followed by a relapse. (Remission means a temporary recovery, and relapse means a return of symptoms.)

Who cannot join the trial?

3 criteria

Patients who are not between the ages of 16 and 35 cannot participate.
Patients who do not have Anorexia Nervosa cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children, prisoners, or those with severe mental illness.

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Region Skane Skanes Universitetssjukhus
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Lund, Sweden

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Investigated drugs

Psilocybin is a substance that is being studied for its potential to help people with anorexia nervosa, a condition where individuals have an intense fear of gaining weight and a distorted body image. In this trial, psilocybin is given to young adults along with psychological support. The goal is to see if it can be safely used and if it helps improve the symptoms of anorexia nervosa. Psilocybin is known for its effects on the brain, which can lead to changes in perception, mood, and thought patterns. Researchers are interested in whether these effects can help people with anorexia nervosa by potentially altering their relationship with food and their body image.

Dry Extract From Psilocybe Cubensis (15-25:1), Extraction Solvent: Methanol

What is already known about the treatment

Psilocybin – Psilocybin is administered orally in the form of capsules or tablets, often accompanied by psychological support. It is currently being studied for its potential use in treating anorexia nervosa, a serious eating disorder. The main therapeutic indication for psilocybin in this context is to help improve mental health and eating behaviors in young adults with anorexia nervosa. At the molecular level, psilocybin works by affecting serotonin receptors in the brain, which can alter mood and perception. It is classified as a psychedelic compound, and its use in medicine is still under investigation, with ongoing clinical trials exploring its safety and effectiveness.

Investigated diseases

Anorexia Nervosa – Anorexia Nervosa is an eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading individuals to restrict food intake severely. This condition often results in significant weight loss and malnutrition. As the disorder progresses, individuals may experience physical symptoms such as fatigue, dizziness, and thinning hair. Psychological symptoms can include anxiety, depression, and obsessive behaviors related to food and body image. Over time, the body's organs can be affected due to lack of nutrition, leading to further health complications. The disorder can persist for years, with periods of improvement and relapse.