[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564770":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":23,"responsibleParty":37,"collaborators":40,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":7,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":7,"studyType":56,"phases":7,"briefSummary":57,"conditions":58,"keywords":7,"overallStatus":60,"whyStopped":7,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"University of California, San Diego","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Rob Knight, PhD","PRINCIPAL_INVESTIGATOR",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Aaron Besterman, MD","CONTACT","8589668145","abesterman@rchsd.org",{"name":19,"role":15,"phone":20,"phoneExt":21,"email":22},"Abbey Albertazzi, MA","8589661700","221939","aalbertazzi@rchsd.org",[24],{"facility":25,"status":7,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":7},"Rady Children's Hospital San Diego","San Diego","California","92123","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-117.16472,32.71571,{"lat":35,"lon":34},{"type":11,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Rob Knight","Professor",[41],{"name":42,"class":6},"Rady Children's Hospital, San Diego","100564770","evaluating-the-role-of-the-microbiome-in-antidepressant-treatment-in-adolescents-100564770",false,"NCT06633497","Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.","Inclusion Criteria:\n\n* Subjects from all ethnic backgrounds will be eligible to participate.\n* Having clinically significant depressive symptoms based on a score \\>40 on the Children's Depression Rating Scale-Revised\n* Prescribed more than 5mg of Fluoxetine (Prozac)\n* Has an identifiable legal guardian.\n\nExclusion Criteria:\n\n* Has been taking a standing psychotropic medication in the past 6 months\n* Has been taking antibiotics or metformin during the past 6 months (known strong effects on gut microbiome)\n* Admitted to RCHSD CAPS post-overdose (potential strong effects on gut microbiome)\n* Currently using nicotine-containing substances (known strong effects on gut microbiome)",true,"ALL","13 Years","17 Years",{"count":54,"type":55},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the role of the human gut microbiome in antidepressant treatment response in adolescents with Major Depressive Disorder (MDD). Specifically, the study aims to collect microbiota samples of adolescents treated with fluoxetine, over the span of 8-weeks, to:\n\n* determine the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression.\n* test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine\n* investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine.\n\nDepression symptom severity will be evaluated upon enrollment and 6-weeks into antidepressant treatment.",[59],"Depression in Adolescence","NOT_YET_RECRUITING","2024-10-31",{"date":63,"type":64},"2024-11-04","ACTUAL",{"date":66,"type":55},"2024-11",{"date":68,"type":55},"2026-10",{"name":5,"class":6},1]