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Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa

RecruitingPhase 2Ages 16 Years - 35 YearsAllRegion Skane
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In plain words

What the trial is, and whether it could suit you

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 w

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Stable contact with a psychiatric unit * Ability to provide informed consent Exclusion Criteria: * 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 * History of stroke, myocardial infarction, or other significant cardiovascular events * Seizure disorders or history of epilepsy * Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia * Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion * Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results * Care under the Swedish Compulsory Psychiatric Care Act (LPT) * Ongoing treatment with medications that have clinically relevant 5-HT2A-receptor antagonistic properties and are therefore expected to directly block or substantially interfere with the pharmacodynamic effects of psilocybin. Such medications require an appropriate washout period prior to psilocybin administration, based on pharmacokinetic properties and clinical judgement. Medications without direct 5-HT2A-antagonistic effects are not excluded on this basis. * BMI \> 21.0 for ≥ 6 consecutive months within the 12 months prior to screening, as documented in medical records.
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What it tests

  • Psilocybin
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Where

1 site
Psykiatrikliniken, Baravägen 1
Lund, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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