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

Recruiting now · Phase 4

Conditions studied: Depressed Insomniac Co-morbid Patients

In brief

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.

Key facts

Study ID: NCT06740188
Run by: Tongji University
People needed: 60
Starts: 2025-01-01
Expected to finish: 2027-12-31
Last updated by the study team: 2025-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Tongji University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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