RecruitingPhase 4NCT06740188

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


Sponsor

Tongji University

Enrollment

60 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether trazodone, an antidepressant with sleep-promoting effects, can increase the amount of deep restorative sleep (NREM stage 3) in patients who have both depression and insomnia at the same time. Deep sleep is important for mood regulation and physical health. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with both depression and non-organic insomnia based on standard psychiatric criteria (DSM-5) - Your depression and sleep scores on standard rating scales are above the threshold for moderate severity - You have not previously taken antidepressants or sleep medications **You may NOT be eligible if...** - You are currently taking antidepressants or sedative/sleep medications - You have taken related medications in the past - You have significant vision, hearing, or understanding difficulties - You have other serious health conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5-hydroxytryptamine balanced antidepressants trazodone

The intervention group was given only 5-hydroxytryptamine balanced antidepressants trazodone

DRUGCitalopram hydrobromide combined with zolpidem

the control group was given citalopram hydrobromide combined with zolpidem


Locations(1)

Tongji University

Shanghai, Shanghai Municipality, China

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NCT06740188