[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Elizabeth Austen Lawson\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100497194","phase-2-oxytocin-effects-on-bone-in-children-with-autism-spectrum-disorder-100497194",false,"NCT05754073","Oxytocin Effects on Bone in Children With Autism Spectrum Disorder","A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder","BOX","Inclusion Criteria:\n\n1. Ages 6 to 18 years old at Randomization\n2. BMI greater than or equal to the 5th percentile\n3. Expert clinical diagnosis of ASD\n4. Availability of parent\u002Fguardian to provide informed consent\n\nExclusion Criteria:\n\n1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density\n2. Other conditions that may contribute to low bone density (e.g., hypogonadism)\n3. Medications that may impact bone other than calcium or vitamin D supplementation, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral glucocorticoids, hormonal contraceptive injection (Medroxyprogesterone acetate (Depo-Provera)\n4. Hyponatremia\n5. Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range\n6. Estimated glomerular filtration rate (eGFR) less than 60\n7. Substance use disorder within the last 6 months\n8. History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT (QTc greater than or equal to 480 msec)\n9. Active seizures within 6 months preceding the Screening visit or the Baseline visit\n10. Subjects who are pregnant, lactating, or who refuse contraception if sexually active\n11. Subjects who have had previous treatment with OXT (within 2 months of Randomization)\n12. Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training\n13. Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol\n14. Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety","ALL","6 Years","18 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.",[28,29],"Autism Spectrum Disorder","Bone Health",[31,32,33,34],"Autism spectrum disorder","Bone density","Oxytocin","Peri-pubertal children","RECRUITING","2026-02-26",{"date":38,"type":39},"2026-03-02","ACTUAL",{"date":41,"type":39},"2023-08-01",{"date":43,"type":22},"2028-08-31",{"name":45,"class":46},"Elizabeth Austen Lawson","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100423076","phase-1-effects-of-intranasal-oxytocin-in-patients-with-arginine-vasopressin-deficiency-100423076","NCT04789148","Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency","Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency - A Pilot Study","Inclusion Criteria:\n\n* Age 18 and above\n* Arginine-vasopressin deficiency\n* Normal FT4 or T4\n* Normal serum\u002Fplasma sodium\n* Stable hormone replacement\n\nExclusion Criteria:\n\n* Active substance use disorder within the last 6 months\n* History of psychosis\n* Suicidal behavior and\u002For active suicidal ideation with plan and\u002For intent, e.g., suicidal ideation of type 4 or type 5 as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), in the last month\n* Medication changes within 4 weeks of enrollment or planned medication changes during the study\n* History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.\n* History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)\n* History of chronic kidney disease stage III and above\n* History of liver cirrhosis\n* Pregnancy or breastfeeding within the last 8 weeks\n* Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)\n* Any significant illness, condition, drug or medical device that the Investigator determines could interfere with study participation, data collection, or safety",{"count":55,"type":22},40,[57],"PHASE1","This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B).\n\nFollowing a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.\n\nIn Part A, thirty participants will be equally randomized to one of six possible groups:\n\n1. 6 IU oxytocin - 24 IU oxytocin - placebo\n2. 6 IU oxytocin - placebo - 24 IU oxytocin\n3. 24 IU oxytocin - 6 IU oxytocin - placebo\n4. 24 IU oxytocin - placebo - 6 IU oxytocin\n5. placebo - 6 IU oxytocin - 24 IU oxytocin\n6. placebo - 24 IU oxytocin - 6 IU oxytocin\n\nFollowing completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.",[60],"Vasopressin Deficiency",[62,63,64,65,66,67,68],"Hypopituitarism","posterior pituitary","oxytocin","psychopathology","anxiety","depressive symptoms","socioemotional functioning","2025-09-10",{"date":71,"type":39},"2025-09-16",{"date":69,"type":39},{"date":74,"type":22},"2026-06",{"name":45,"class":46},1,""]