[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585193":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":99,"collaborators":101,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":26,"enrollmentInfo":116,"targetDuration":26,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo then Atomoxetine","PLACEBO_COMPARATOR","Participants receive placebo for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose).",[13,14],"Drug: Atomoxetine","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Atomoxetine then Placebo","ACTIVE_COMPARATOR","Participants receive atomoxetine for 16 weeks (4 weeks titration + 12 weeks at target dose), followed by washout period, then placebo for 16 weeks (4 weeks titration + 12 weeks at target dose).",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Atomoxetine","Initial dose 40 mg, day 7 dose 60 mg, day 14 dose 80 mg, day 21 dose 100 mg (target dose)",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo oral capsule",[16,9],[32,36],{"name":33,"affiliation":34,"role":35},"Joan C Han, MD","Mount Sinai Kravis Children's Hospital","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Ashley H Shoemaker, MD, MSCI","Vanderbilt University Medical Center",[40],{"name":33,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","212-241-3744","301-312-7","joan.han@mountsinai.org",[46,64,80],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Mount Sinai Hospital","RECRUITING","New York","10029","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.00597,40.71427,{"lat":57,"lon":56},[60,62],{"name":61,"role":41,"phone":42,"phoneExt":26,"email":44},"Joan Han, MD",{"name":63,"role":35,"phone":26,"phoneExt":26,"email":26},"Joan Han",{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":51,"countryCode":52,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Nationwide Children's Hospital","NOT_YET_RECRUITING","Columbus","Ohio","43205",{"type":54,"coordinates":71},[72,73],-82.99879,39.96118,{"lat":73,"lon":72},[76,79],{"name":61,"role":41,"phone":77,"phoneExt":26,"email":78},"614-722-4170","joan.han@nationwidechildrens.org",{"name":61,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":38,"status":66,"city":81,"state":82,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Nashville","Tennessee","37232",{"type":54,"coordinates":85},[86,87],-86.78444,36.16589,{"lat":87,"lon":86},[90,94,97],{"name":91,"role":41,"phone":92,"phoneExt":26,"email":93},"Jenny Leshko, RN","615-343-8116","jenny.leshko@vumc.org",{"name":95,"role":41,"phone":92,"phoneExt":26,"email":96},"Ashley Shoemaker, MD, MSCI","ashley.h.shoemaker@vumc.org",{"name":98,"role":35,"phone":26,"phoneExt":26,"email":26},"Ashley Shoemaker",{"type":35,"investigatorFullName":63,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor of Pediatrics",[102,103],{"name":38,"class":6},{"name":104,"class":105},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100585193","phase-2-atomoxetine-in-melanocortin-obesity-syndrome-100585193",false,"NCT06899178","Atomoxetine in Melanocortin Obesity Syndrome","A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults With Melanocortin Obesity Syndrome","MCOS","Inclusion criteria:\n\n* Age 6 years and above\n* Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria. If testing was done in a research lab, it will be confirmed by a CLIA-approved lab prior to randomization.\n* Obesity defined as BMI ≥30 kg\u002Fm2 in adults or ≥95th percentile for age and sex in children\n\nExclusion criteria:\n\n* Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine, or any other stimulant medication in the past 30 days. If on other ADHD medications, such as guanfacine and clonidine, must be on a stable dose for \\>3 months.\n* Weight loss \\>5% in the past 3 months.\n* Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for \\>3 months.\n* Inability to swallow capsules.\n* History of hypersensitivity to atomoxetine.\n* Narrow angle glaucoma.\n* History of pheochromocytoma.\n* Uncontrolled Stage 2 hypertension (≥95th percentile + 12 mmHg or \\>140\u002F90, whichever is lower) at screening. If on antihypertensive medication, must be on stable dose for \\>3 months.\n* Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \\>3x upper limit of normal)\n* Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months\n* History of a cardiac arrhythmia (not including bradycardia)\n* Current use of monoamine oxidase inhibitors\n* Pregnancy or intention to become pregnant during the next year\n* History of Major Depressive Disorder in the past 2 years, lifetime history of suicide attempt, history of any suicidal behavior in the past month, history of other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder)\n* PHQ-9 score is ≥15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month\n* Unable to comply with study procedures in the opinion of the investigator","ALL","6 Years",{"count":117,"type":118},20,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.",[124,112],"Melanocortin Obesity Syndrome",[126,127,128,23,129,130],"Obesity","BDNF","MC4R","Energy balance","Weight loss","2026-08-04",{"date":133,"type":134},"2026-08-07","ACTUAL",{"date":136,"type":118},"2026-09-01",{"date":138,"type":118},"2028-06",{"name":5,"class":6},3]