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

Study acronym: psiAN
StatusRecruiting
PhasePhase 2
Started2026-07-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2026 → Oct 1, 2027
See other at-risk trials from Region Skane

Amendment history

2026-08-12
Study Status, Study Description, Outcome Measures, Eligibility v3
Primary completion pushed: 2026-10-01 → 2027-10-01
Start date2026-04-20→2026-07-20
Eligibility criteria+523 characters
Inclusion Criteria: Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission. Have experienced at least one period of remissionweight (restoration to a minimum BMI of 17) followed by asubsequent relapseweight loss. Age 16-35 BMI >16 Stable contact with a psychiatric unit Ab [...] disorder, refusal of birth control, lifetime psychedelic use, unable to washout ongoing medications* that would interfere negatively with the study drug. Cardiovascular conditions Resting systolic blood pressure > [...] are under the Swedish Compulsory Psychiatric Care Act (LPT) Ongoing treatment with medications [...] [...]
Study description+535 characters
[...] e, liver, kidney), electrocardiogram (ECG), informed consent (with a 2-week consideration period), pregnancy test and urine toxicology (U-tox). The time from [...] re eligibility and understanding of the study requirements. A brief telephone pre-screening is performed before the screening visit to avoid unnecessary visits for patients. A minimum of two weeks must elapse between informed consent and activation into the therapeutic manual. Preparation Phase Preparation Session 1 & Baseline Assessmen [...] ventory (TIPI) Honesty-Humility Scale (HH) Vital signs, ECG, fasting glucose, urine drug screening, fMRI, [...] [...]
2026-03-04
Not Yet Recruiting→Recruiting Study Status, Study Description, Outcome Measures, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Start date2025-10-01→2026-04-20
Secondary endpoints17 to 18 entries
To evaluate changes in the metric assessment of perceived body size.
Study description+1,428 characters
[...] and conduct qualitative analysis of subjective experiences. Neuroimaging will investigate changes in brain resting state connectivity (measured by fMRI), and commonly used task-based fMRI paradigms. The task-based paradigms will involve food-related conditions, commonly used in the population (Celeghin et al., 2023; Bronleigh et al., 2022) as well as establi [...] Trial Design and Procedures This is a phase II, open-label, [...] erventions data are collected in patient journal registers. Pre-Study Activity Following ethical approval, a focus group will be conducted with patients with anorexia nervosa in tw [...] [...]
Study sitesdetails revised at 1 of 1 site
Publications30 entries, revised
Halmi KA, Goldberg SC, Casper RC, Eckert ED, Goldberg SC, Davis JM. PretreatmentUnique predictorsfeatures associated with age of outcomeonset inof anorexia nervosa. BrPsychiatry J PsychiatryRes. 1979 JanOct;1341(2):71209-815. doi: 10.11921016/bjp0165-1781(79)90063-5.134.1.71.
2025-09-22
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 17 entries
Study description-542 characters
[...] mately five times higher than that of the general population (Arcelus et al., 2011). AN affects multiple organ systems due to severe weight los [...] s to a substantial decline in health-related quality of life (Westmoreland et al. 2016, Dejong et al., 2016). While psychotherapies have shown partial efficacy, data su [...] ts recover within four years, and 20% remain chronically ill (Steinhausen, 2002). Relapse rates exceed 50% among those who recover, underscoring the need for more effective treatments (Khalsa, 2017). Research suggests that several psychological factors, such [...] ibute to the persistence of sev [...]
Study title-64 characters
[...] Psychological Support in Young Adults With Anorexia Nervosa: A Randomized Controlled Trial Compared With Treatment as Usual
2025-09-09
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
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.
Trial Details
NCT Number NCT07169747
Lead Sponsor Region Skane
Collaborators: Sten Theanders fond, Lions Forskningsfond Skåne, NorrskenMind
Conditions Anorexia Nervosa
Enrollment 40 participants
Start Date 2026-07-20
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14