[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anorexia-nervosa-dsm-iv-revised-criteria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anorexia-nervosa-dsm-iv-revised-criteria":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601682","phase-1-magnetic-resonance-guided-focused-ultrasound-bilateral-capsulotomy-for-refractory-anorexia-nervosa-with-comorbid-obsessive-compulsive-disorder-or-major-depressive-disorder-100601682",false,"NCT07113665","Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder","Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Anorexia Nervosa With Co-morbid Obsessive Compulsive Disorder or Major Depressive Disorder","Inclusion Criteria:\n\n1. Men and women ≥18 and ≤65 years of age, inclusive.\n2. Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.\n3. DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and\u002For Major depressive disorder.\n4. Treatment refractoriness indicated by any of:\n\n   1. Duration of illness more than 10 years with no more than three months of remission in terms of weight;\n   2. At least three attempts at expert hospital based treatment that were not successful or where there was no sustained response to treatment;\n   3. A pattern of increased medical instability requiring at least two episodes of emergency\u002Finvoluntary re-feeding and lasting at least two years;\n5. Ability to provide informed consent\u002Fcompetent to make medical decisions.\n\nExclusion Criteria:\n\n1. Patients with unstable cardiac status \\[e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP \\> 100 on medication)\\]\n2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.\n3. Laboratory biochemical evidence of abnormal bleeding and\u002For coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)\n4. Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage\n5. Untreated, uncontrolled sleep apnea\n6. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure\n7. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment\n8. Are participating or have participated in another clinical trial in the last 30 days\n9. Patients unable to communicate with the investigator and staff.\n10. Presence of significant cognitive impairment\n11. History of psychosis on clinical evaluation.\n12. Patients with brain tumors already known or revealed on pretreatment MRI\n13. Currently pregnant (as determined by history and serum HCG) or lactating.\n14. Chemical abuse or dependence within the previous six months\n15. Presence of a metabolic pathology interfering with eating or digestion (e.g. diabetes).\n16. Body mass index (BMI) less than 13","ALL","18 Years","65 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). The main questions it aims to answer are:\n\n1. Can MR-guided focused ultrasound capsulotomy be safely delivered through an intact skull in patients with treatment-refractory anorexia nervosa and comorbid OCD and\u002For MDD, with a safety and side-effect profile comparable to traditional radiofrequency neurosurgical approaches?\n2. Does MRgFUS capsulotomy produce clinical outcomes comparable to open surgical ablative procedures-specifically, improvements in anxiety, mood, quality of life, anorexia nervosa psychopathology, habit formation, and weight-in patients with treatment-refractory anorexia nervosa?\n\nParticipants will:\n\n1. Undergo baseline imaging and clinical assessments\n2. Receive a single MRgFUS capsulotomy targeting the ALIC\n3. Be monitored for 24 months post-treatment to assess adverse events, quality of life, and symptom changes using standardized clinical and neuropsychiatric measures",[27],"Anorexia Nervosa (DSM-IV Revised Criteria)",[29,30,31,32,33],"Anorexia Nervosa","MR-guided Focused Ultrasound","bilateral capsulotomy","Obsessive Compulsive Disorder","Major Depressive Disorder","RECRUITING","2025-08-08",{"date":37,"type":38},"2025-08-14","ACTUAL",{"date":40,"type":21},"2025-08",{"date":42,"type":21},"2028-08",{"name":44,"class":45},"Sunnybrook Health Sciences Centre","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100570841","biomarkers-in-ev-associated-with-marrow-adiposity-in-anorexia-100570841","NCT06712485","Biomarkers in EV Associated With Marrow Adiposity in Anorexia","Identification of Biomarkers in Extracellular Vesicles Associated With Marrow Adiposity and Bone Deterioration Caused by Nutritional Deficiencies","VE_BMAT_AN","Inclusion Criteria:\n\nFor AN group:\n\n* Diagnosis of active AN according to DSM-5 criteria\n* BMI of less than 17kg\u002Fm2\n* Present amenorrhoea in the 3 months prior to the start of the study.\n\nFor AN-R group:\n\n* Achieved weight gain of more than 85%.\n* Normal menstruation in the last 3 months.\n\nFor Control group:\n\n* Population of the same age and gender as the AN and AN-R groups.\n* If pubertal population, presenting a chronological age of ± 2 years.\n* Normal menstruation\n* Normal BMI (\\>18.5 kg\u002Fm2)\n* No presence of previous dietary transtrons.\n\nExclusion Criteria:\n\n* Not receiving oestrogens, contraceptives or glucocorticoids in the 3 months prior to the start of the study.\n* Not to suffer from chronic diseases, such as diabetes, pathologies affecting the bone system or thyroid function.\n* Do not take calcium or vitamin supplements.",true,{"count":57,"type":21},30,"OBSERVATIONAL","The aim of this observational study is to identify biomarkers in extracellular vesicles associated with medullary adiposity occurring in patients with anorexia nervosa. The main question it aims to answer is:\n\nCan this medullary adiposity be associated with the bone deterioration observed in this population?\n\nParticipants will be assessed for body composition and a blood sample will be taken by non-invasive techniques.",[61,27],"Anorexia Nervosa Restricting Type",[63,64,65,66,67],"Extracellular Vesicles","Bone Deterioration","Biomarkers","Bone Marrow Adipose Tissue","Nutritional Deficiencies","NOT_YET_RECRUITING","2025-05-05",{"date":71,"type":38},"2025-05-07",{"date":73,"type":21},"2025-05-15",{"date":75,"type":21},"2026-07-31",{"name":77,"class":45},"Maimónides Biomedical Research Institute of Córdoba"]