[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572970":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Tongji University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone.",[13],"Drug: 5-hydroxytryptamine balanced antidepressants trazodone",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","The control group was given citalopram hydrobromide combined with zolpidem.",[19],"Drug: Citalopram hydrobromide combined with zolpidem",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","5-hydroxytryptamine balanced antidepressants trazodone","The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Citalopram hydrobromide combined with zolpidem","the control group was given citalopram hydrobromide combined with zolpidem",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Meiling Liu, M.M.","CONTACT","86+2168306699","tongjie_room@126.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Shanghai","Shanghai Municipality","200124","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"Meiling Liu, PhD.","+86-13917639849",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jie Tong","Prof.","100572970","phase-4-trazodone-on-nrem-sleep-stage--in-depressed-insomniac-co-morbid-patients-100572970",false,"NCT06740188","Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients","Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: A Randomized Controlled Trial","n-REMSS","Inclusion Criteria:\n\n* Outpatient or inpatient patients;\n* 18 years old ≤ 65 years old;\n* Simultaneously meet the diagnostic criteria for depression and non organic insomnia in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in the United States;\n* 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points;\n* Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points;\n* Never used related antidepressants and sedative hypnotic drugs;\n* Has a certain level of visual and auditory resolution, and no comprehension barriers;\n* Capable of independently completing scale measurements;\n* Education level above primary school;\n* Obtain written informed consent from the patient, and obtain written informed consent from the legal guardian if the patient is incapacitated during the onset of the illness.\n\nExclusion Criteria:\n\n* Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc\n* Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage;\n* Patients with narrow angle glaucoma;\n* History of epilepsy and febrile seizures;\n* Individuals with a history of drug use;\n* Positive for syphilis specific antibody and AIDS antibody;\n* According to risk assessment, there are currently serious suicide attempts or individuals who are overly agitated Pregnant or lactating women, or those planning to conceive in the near future;\n* Laboratory tests indicate the presence of liver and kidney function impairment in individuals;\n* There are other individuals who meet the relevant contraindications for antidepressants.","ALL","18 Years","65 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","This study used polysomnographic technology and randomly selected 60 patients who met the diagnostic criteria for depression and non-organic insomnia as stipulated in DSM-5 into an intervention group (n=30) and a control group (n=30). The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone, while the control group was given citalopram hydrobromide combined with zolpidem. Both groups underwent PSG at baseline and 1 week after medication, and were assessed with the 17-item Hamilton Depression Rating Scale, Zung Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, Arnsworth Insomnia Severity Scale, Antidepressant Side Effects Checklist, and the Drug Dependence Scale neuropsychological assessment at baseline, 1, 2, and 4 weeks after medication. The study aimed to explore the effects of single use of SMAs class antidepressants versus combination with other antidepressants on non-rapid eye movement sleep stage III in patients with depression and insomnia comorbidity, and to compare the effects of depression and insomnia in the two groups.",[78],"Depressed Insomniac Co-morbid Patients",[80,81,82,83],"Trazodone","Non-rapid Eye Movement Sleep Stage","depression","insomnia","2025-02-16",{"date":86,"type":87},"2025-02-19","ACTUAL",{"date":89,"type":87},"2025-01-01",{"date":91,"type":72},"2027-12-31",{"name":5,"class":6},1]