[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573683":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group","EXPERIMENTAL","Jieyu Chufan Capsules Strength: 0.4 g\u002Fcapsule, 3 × 12 capsules\u002Fplate\u002Fbox Administration: 4 capsules, tid, 8 weeks",[13],"Drug: Jieyu Chufan Capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Jieyu Chufan Capsules Placebo Strength: 0.4 g\u002Fcapsule, 3 × 12 capsules\u002Fplate\u002Fbox. Administration: 4 capsules, tid; 8 week",[19],"Drug: Jieyu Chufan Capsules simulant",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Jieyu Chufan Capsules","4 capsules, tid; 8 weeks",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Jieyu Chufan Capsules simulant",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Jin Liu, Doctor","CONTACT","+86 19832188333","383505858@qq.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Lingjiang Li","Chief physician","100573683","phase-4-a-randomized-double-blind-placebo-controlled-multicenter-clinical-study-on-the-treatment-of-depression-with-jieyu-chufan-capsules-100573683",false,"NCT06749470","A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study on the Treatment of Depression with Jieyu Chufan Capsules","JOYS","Inclusion criteria:\n\n1. Aged 18-65 years (inclusive);\n2. With first-episode or relapsed depression that meets the DSM-5 diagnostic criteria;\n3. With a Hamilton's Depression Scale (HAMD-17) score of ≥18 at enrollment;\n4. Receiving no antidepressants within 2 weeks (fluoxetine within 6 weeks) prior to enrollment;\n5. Willing to sign the informed consent form (ICF).\n\nExclusion criteria:\n\n1. Meeting the DSM-5 diagnostic criteria for mental disorders other than depression (e.g., patients with schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, compulsive and related disorders, etc.);\n2. With refractory depression (no response to adequate treatment with 2 or more antidepressants) as determined by the investigator or previously diagnosed;\n3. At a significant risk of suicide (HAMD-17 Item 3 (suicide) score ≥3) as judged by the investigator, or with a history of suicide attempts in the last year;\n4. Receiving non-drug therapies, such as electric convulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and systematic psychotherapy 10 or more times in the last 6 months;\n5. With other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumor, epilepsy, and severe rheumatism;\n6. With clinically significant abnormalities in 12-lead ECG that may affect the safety of the subject, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significantly prolonged QTc (QTc \\>450 ms in men and \\>470 ms in women);\n7. With severe hepatic and renal insufficiency, i.e., aspartate transaminase (AST) ≥1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT) ≥1.5 × ULN, and serum creatinine (Scr) ≥1.5× ULN;\n8. Allergic to the investigational drug or its ingredients;\n9. In lactation, of childbearing potential, or planning to be pregnant;\n10. With alcohol and drug dependence;\n11. Participating in another clinical study within 1 month prior to enrollment or for the time being.\n12. Not suitable for participation in this study due to potential risks or other factors as considered by the investigator.","ALL","18 Years","65 Years",{"count":51,"type":52},480,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","To evaluate the efficacy of Jieyu Chufan Capsules, with placebo as the control, in combination with SSRIs in patients with moderate and severe depression.\n\nTo observe the safety of Jieyu Chufan Capsules and its effects in improving the side effects of SSRIs.",[58],"Major Depressive Disorder (MDD)",[23,60,58],"TCM","NOT_YET_RECRUITING","2024-12-23",{"date":64,"type":65},"2024-12-27","ACTUAL",{"date":67,"type":52},"2024-12-22",{"date":69,"type":52},"2026-12-31",{"name":5,"class":6}]