[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608560":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fluoxetine combined with selenium yeast therapy","EXPERIMENTAL","In this group, participants will receive standard fluoxetine treatment along with adjunctive selenium yeast supplementation at a daily dose of 60-200 μg, aiming to investigate the role and mechanisms of selenium yeast in fluoxetine therapy.",[13],"Drug: selenium yeast supplementation",{"label":15,"type":16,"description":17,"interventionNames":18},"Fluoxetine combined with placebo therapy","PLACEBO_COMPARATOR","Participants in this group, in addition to receiving conventional fluoxetine treatment, were administered 60-200 µg per day of a placebo identical in appearance and odor to selenium yeast as adjunctive therapy. The aim was to investigate the role of selenium yeast in fluoxetine treatment and to clarify whether it enhances the therapeutic effect.",[19],"Drug: Placebo yeast supplementation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","selenium yeast supplementation","In this intervention, patients will receive adjunctive selenium yeast supplementation at a daily dose of 60-200 μg in addition to fluoxetine. Symptom rating scales, biospecimen collection, and brain MRI will be conducted at baseline, week 4, and week 8 to investigate the adjunctive role of selenium in fluoxetine treatment for depression.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo yeast supplementation","In this intervention, patients will receive standard fluoxetine treatment combined with placebo yeast supplementation (60-200 μg\u002Fday), which is identical in appearance and odor to selenium yeast. The aim is to clarify the specific role of selenium in the treatment of depression.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zhou Xinyu","CONTACT","15823996993","zhouxinyu@cqmu.edu.cn",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","40000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],106.55771,29.56026,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xinyu Zhou","professor","100608560","phase-2-selenium-supplementation-for-improving-depression-in-children-and-adolescents-efficacy-and-mechanistic-study-100608560",false,"NCT07203144","Selenium Supplementation for Improving Depression in Children and Adolescents: Efficacy and Mechanistic Study","Inclusion Criteria:\n\n* Aged 12-18 years;\n* Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), using the K-SADS-PL diagnostic tool;\n* A score of ≥28 on the Children's Depression Rating Scale-Revised (CDRS-R);\n* Adequate visual and auditory abilities to complete the study;\n* Willingness to participate in the study with informed consent signed by both the participant and a legal guardian.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders such as bipolar disorder, schizophrenia, bulimia nervosa, anorexia nervosa, or primary obsessive-compulsive disorder;\n* Those with severe physical illnesses or other life-threatening conditions; patients in a current depressive episode with a clear suicidal plan or history of suicide attempt;\n* Individuals with a history of substance or drug abuse;\n* Those requiring immediate hospitalization for psychiatric disorders;\n* Patients currently taking medications contraindicated with the investigational drug or that may interfere with its efficacy;\n* Those who have received modified electroconvulsive therapy (MECT) within the past 12 months;\n* Individuals allergic to selenium yeast protein, including those with allergic rhinitis, gastrointestinal sensitivity, allergic constitution, or autoimmune diseases such as Graves' disease or Hashimoto's thyroiditis;\n* Patients with contraindications to magnetic resonance imaging (MRI);\n* Aand left-handed individuals.","ALL","12 Years","18 Years",{"count":67,"type":68},172,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","The purpose of this study is to investigate the role and mechanisms of selenium in depression among children and adolescents, aiming to provide new insights for understanding the pathogenesis and treatment of depression in this population.",[74],"Depression - Major Depressive Disorder","NOT_YET_RECRUITING","2025-12-21",{"date":78,"type":79},"2025-12-29","ACTUAL",{"date":81,"type":68},"2025-12-31",{"date":83,"type":68},"2027-04-01",{"name":5,"class":6},1]