[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534428":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"pregnenolone","EXPERIMENTAL","Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks",[13],"Dietary Supplement: pregnenolone",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","Participants will take placebo twice per day for four weeks",[19],"Other: placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo pills are identical-appearing capsules containing cellulose",[15],[30],{"name":31,"affiliation":32,"role":33},"Katherine Burdick, PhD","Columbia University","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Aleta Wiley, MPH","CONTACT","617-975-8706","awiley3@bidmc.harvard.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":25,"phoneExt":25,"email":25},"Aleta Wiley",{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Hadine Joffe","Professor of Psychiatry","100534428","study-on-allopregnanolone-and-depression-in-women-across-the-menopause-transition-100534428",false,"NCT06238700","Study on Allopregnanolone and Depression in Women Across the Menopause Transition","Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition","SADIE-P","Inclusion Criteria:\n\n* Healthy women ages 40 to 60 years in the menopause transition\n* Depressive symptoms\n* Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study\n* Able to read Arabic numerals and perform simple arithmetic\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Systemic hormone therapy\n* Contraindicated medications with pregnenolone\n* Systemic corticosteroid\n* Other psychiatric illnesses that are considered to be primary\n* Current suicidal ideation\n* Active substance use disorders\n* Unstable medical conditions\n* Obstructive sleep apnea or other primary sleep disorders\n* Abnormal hepatic and renal function\n* Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone\n* History of head injury resulting in loss of consciousness \\> 20 min\n* Inability to comply with barrier contraceptive methods\n* Known intellectual disability\n* Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition\n* Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data\n* Inability to comply with study procedures","FEMALE","40 Years","60 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.",[79],"Depression","2026-05-12",{"date":82,"type":83},"2026-05-14","ACTUAL",{"date":85,"type":83},"2024-05-14",{"date":87,"type":73},"2027-08-31",{"name":5,"class":6},1]