[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605992":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":58,"collaborators":61,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Region Skane","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin with Psychological Support","ACTIVE_COMPARATOR","This arm will receive two separate doses of psilocybin 25 mg administered four weeks apart, with psychological support, along side treatment as usual. The psychological support includes preparation sessions before, support during, and integration sessions after psilocybin intake.",[13],"Drug: Psilocybin",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual","NO_INTERVENTION","This arm will receive treatment as usual which includes specialised care offered in an eating disorder unit in Region Skåne, Sweden. If the active treatment arm is determined to be safe, tolerable, and preliminarily effective during the follow-up assessment at 6 months, participants in the control group will have the option to switch to the active treatment while maintaining their usual specialised care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Psilocybin","The 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.",[9],[26],{"name":27,"affiliation":28,"role":29},"Pouya Movahed Rad, Associate Professor","Department of Clinical Sciences, Lund University, Sweden","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"David Sjöström, MD, PhD-student","CONTACT","+46739075390","david.sjostrom@med.lu.se",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Olea Schau Rybäck, MD, PhD-student","+46736698415","olea.schau_ryback@med.lu.se",[41],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Psykiatrikliniken, Baravägen 1","RECRUITING","Lund","22240","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],13.19321,55.70584,{"lat":52,"lon":51},[55,56,57],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":29,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Pouya Movahed Rad","Associate Professor and Senior Consultant in Psychiatry",[62,65,67],{"name":63,"class":64},"Sten Theanders fond","UNKNOWN",{"name":66,"class":64},"Lions Forskningsfond Skåne",{"name":68,"class":64},"NorrskenMind","100605992","phase-2-safety-therapeutic-potential-and-mechanisms-of-two-psilocybin-doses-administered-with-psychological-support-in-young-adults-with-anorexia-nervosa-100605992",false,"NCT07169747","Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa","The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults","psiAN","Inclusion Criteria:\n\n* Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission.\n* Have experienced at least one period of weight restoration to a minimum BMI of 17 followed by subsequent weight loss.\n* Age 16-35\n* BMI \\>16\n* Stable contact with a psychiatric unit\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use.\n* Cardiovascular conditions\n* Resting systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg at screening or baseline\n* Clinically significant arrhythmias, tachycardia and QT prolongation\n* History of stroke, myocardial infarction, or other significant cardiovascular events\n* Seizure disorders or history of epilepsy\n* Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia\n* 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\n* Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results\n* Care under the Swedish Compulsory Psychiatric Care Act (LPT)\n* 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.\n* BMI \\> 21.0 for ≥ 6 consecutive months within the 12 months prior to screening, as documented in medical records.","ALL","16 Years","35 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","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.\n\nThe main questions this study aims to answer are:\n\n* Is psilocybin with psychological support safe and well-tolerated?\n* Does psilocybin with psychological support help lower symptoms of anorexia nervosa?\n* How might psilocybin work in the brain to support recovery from anorexia?\n\nThis 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.\n\nParticipants will:\n\n* Be between 16 and 35 years old and have anorexia nervosa\n* Take psilocybin (25 mg) by mouth two times, four weeks apart\n* Receive psychological support before, during, and after each dosing session (including preparation and integration sessions)\n* Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work\n* Share their personal experiences as part of a qualitative interview\n\nThis 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.",[88],"Anorexia Nervosa",[22,88,90,91,92,93],"Young adults","fMRI","BDNF","Adolescents","2026-08-12",{"date":96,"type":97},"2026-08-14","ACTUAL",{"date":99,"type":82},"2026-07-20",{"date":101,"type":82},"2027-10-01",{"name":5,"class":6},1]