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Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients

RECRUITINGPhase 4Sponsored by Tongji University
Actively Recruiting
PhasePhase 4
SponsorTongji University
Started2025-01-01
Est. completion2026-12-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Depressed Insomniac Co-morbid PatientsDepression

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