[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635404":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":55,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Duke Kunshan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychotropic Drugs","ACTIVE_COMPARATOR","1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime)\n2. Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime)\n\nPatients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms",[13],"Drug: Psychotropic Drugs",{"label":15,"type":16,"description":17,"interventionNames":18},"Acupuncture","EXPERIMENTAL","Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3)",[19],"Other: Acupuncture",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime)\n2. Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime)\n\nPatients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms\n\nThe treatment is planned for 4 weeks. After 2 weeks, patients are invited for a check-in visit but there will be no change in the treatment prescribed for 4 weeks",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Manual acupuncture (no sham) will be compared to medication. Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) (29, 30)\n\nOperational Procedure:\n\n1. Patient Position: Supine position.\n2. Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian).\n3. Disinfection: Strict disinfection protocols must be performed prior to needling.\n4. Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi).\n5. Needle Retention Time: 20 minutes.\n6. Treatment Regimen:\n\n   * Frequency: 3 sessions per week (Monday, Wednesday, and Friday).\n   * Course of Treatment: 9 to 10 sessions per course.",[15],[30],{"name":31,"affiliation":5,"role":32},"Claudia Nisa","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Claudia F. Nisa","CONTACT","008618151144079","claudia.nisa@duke.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine","RECRUITING","Kunshan","Jiangsu","China","CN",{"type":48,"coordinates":49},"Point",[50,51],120.95431,31.37762,{"lat":51,"lon":50},{"type":32,"investigatorFullName":31,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Assistant Professor of Behavioral Science",[56,58,61],{"name":57,"class":6},"Kunshan Hospital of Traditional Chinese Medicine",{"name":59,"class":60},"Kunshan Mental Health Center","UNKNOWN",{"name":62,"class":63},"National Natural Science Foundation of China","OTHER_GOV","100635404","phase-4-comparing-acupuncture-with-medication-to-reduce-depression-anxiety-and-comorbid-sleep-disorders-in-china-100635404",false,"NCT07552246","Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China","Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint","Inclusion Criteria:\n\n1. Chinese nationals 18-65 years old\n2. At least one of the screening scores below suggestive of depression\u002Fanxiety tendencies:\n\n   1. Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27)\n   2. Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25)\n\nExclusion Criteria:\n\n1. Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment;\n2. Patients with a risk of suicide;\n3. Patients with a history of head trauma, loss of consciousness, or severe mental disorders;\n4. Patients with drugs or alcohol abuse;\n5. Patients who have received physical treatment methods within the past 3 months;\n6. Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months;\n7. Patients with severe skin lesions or skin diseases.","ALL","18 Years","65 Years",{"count":75,"type":76},180,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China.",[82,83],"Anxiety Depression","Sleep",[85,15,86,87,88],"Depression","Antidepressants","anxiety","sleep","2026-07-28",{"date":91,"type":92},"2026-07-29","ACTUAL",{"date":94,"type":92},"2026-04-01",{"date":96,"type":76},"2027-12-31",{"name":5,"class":6},1]