[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressed-insomniac-co-morbid-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressed-insomniac-co-morbid-patients":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Depressed Insomniac Co-morbid Patients",[30,31,32,33],"Trazodone","Non-rapid Eye Movement Sleep Stage","depression","insomnia","RECRUITING","2025-02-16",{"date":37,"type":38},"2025-02-19","ACTUAL",{"date":40,"type":38},"2025-01-01",{"date":42,"type":22},"2027-12-31",{"name":44,"class":45},"Tongji University","OTHER"]