The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking.
The main questions this study aims to answer are:
* Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia?
This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden.
Participants will:
* Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview
This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.
Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission.
Have experienced at least one period of weight restoration to a minimum BMI of 17 followed by subsequent weight loss.
Age 16-35
BMI >16
Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use.
Cardiovascular conditions
Resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg at screening or baseline
Clinically significant arrhythmias, tachycardia and QT prolongation
Parallel
Psilocybin
DrugThe intervention consists of two oral doses of 25 mg synthetic psilocybin administered in a controlled clinical setting, combined with psychological support. The psychological support includes preparatory sessions prior to psilocybin administration, support during the drug experience and integration sessions following each dosing session.
To assess the safety and tolerability of psilocybin 25 mg in young adults with anorexia nervosa, as measured by incidence of adverse events (AEs) and serious adverse events (SAEs).
Adverse events (AEs) refers to any unwelcome medical occurrence in a patient who has been administered psilocybin or TAU, which may not necessarily be caused by the treatment. Serious Adverse Event (SAE) includes any medical incident or effect, irrespective of dosage, that a) leads to death, b) is life-threatening, c) necessitates hospitalization, or d) results in persistent or significant disability or incapacity. Events will be assessed by the clinical team for causality, intensity, and seriousness and potential relationship to treatment (psilocybin or TAU). All AEs will be categorized based on their severity and likelihood of treatment attribution.
To evaluate the efficacy of two doses of psilocybin, administred with psychological support, in reducing AN symptoms compared to TAU, as measured by time to response, time to remission and time to relapse.
Response defined as a significant improvement in weight and psychological symptoms: 1) BMI Increase: ≥10% increase in BMI from baseline or 2) reaching a BMI ≥18.5 if achievable within the study period. Remission defined as achieving and maintaining weight restoration and psychological well-being, with no significant symptoms of anorexia nervosa: 1\) Weight Restoration of BMI ≥18.5 sustained for at least four weeks, or 2) a weight within 90-95% of ideal body weight adjusted for age and height. Relapse defined as: 1) ≥7 % decrease in BMI compared to post-hospitalization baseline BMI; 2) Re-hospitalization for anorexia nervosa-related complications; 3) Initiation of additional intensive psychiatric or nutritional interventions, including day-patient or inpatient programs; or 4) Self-reported significant deterioration in eating disorder symptoms as assessed by validated scales such as the Eating Disorder Examination Questionnaire 6.0.
Assess potential mechanisms of action through neuroimaging (fMRI), before and after the two-dose psilocybin treatment, administered with psychological support
Investigate potential mechanisms of action by examining changes in brain resting-state connectivity (measured with fMRI) and task-based fMRI responses from baseline to the primary endpoint. Task paradigms will include food-related conditions commonly used in this population, as well as established paradigms assessing reward anticipation.
Changes in serum brain-derived neurotrophic factor (BDNF) levels from before and after treatment with two doses of 25 mg psilocybin, administered with psychological support.
Serum BDNF will be measured in blood samples to investigate potential mechanisms of action.
To conduct a qualitative analysis of how participants, their relatives, and therapists experience and perceive the intervention
Qualitative analysis will be done based on semi-structured interviews, investigating the experience of the intervention from the above mentioned parts. Data will be analyzed thematically to identify common themes and patterns across participants' reports.
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Region Skane
Lead sponsor
Sten Theanders fond
Collaborator
Lions Forskningsfond Skåne
Collaborator
NorrskenMind
Collaborator
