Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients
NCT06740188
Summary
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.
Eligibility
Inclusion Criteria: * Outpatient or inpatient patients; * 18 years old ≤ 65 years old; * 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; * 17 items of Hamilton Depression Rating Scale (HAMD-17) with a total score of ≥ 17 points; * Pittsburgh Sleep Quality Index (PSQI) ≥ 16 points; * Never used related antidepressants and sedative hypnotic drugs; * Has a certain level of visual and auditory resolution, and no comprehension barriers; * Capable of independently completing scale measurements; * Education level above primary school; * 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. Exclusion Criteria: * Patients with comorbidities such as schizophrenia, schizophrenia, bipolar disorder, mental retardation, pervasive developmental disorder, delirium, dementia, cognitive impairment, alcohol dependence, etc * Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, craniocerebral trauma, cerebral ischemia or hemorrhage; * Patients with narrow angle glaucoma; * History of epilepsy and febrile seizures; * Individuals with a history of drug use; * Positive for syphilis specific antibody and AIDS antibody; * 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; * Laboratory tests indicate the presence of liver and kidney function impairment in individuals; * There are other individuals who meet the relevant contraindications for antidepressants.
Conditions2
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06740188