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RECRUITING
NCT06740188
PHASE4

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

Sponsor: Tongji University

View on ClinicalTrials.gov

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.

Official title: Impact of Trazodone on Non-rapid Eye Movement Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-01

Completion Date

2027-12-31

Last Updated

2025-02-19

Healthy Volunteers

No

Interventions

DRUG

5-hydroxytryptamine balanced antidepressants trazodone

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

DRUG

Citalopram hydrobromide combined with zolpidem

the control group was given citalopram hydrobromide combined with zolpidem

Locations (1)

Tongji University

Shanghai, Shanghai Municipality, China