NCT06740188

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not 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.

Conditions

• Depressed Insomniac Co-morbid Patients

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-12-18
• Last updated: 2025-02-19

Locations

1 site across 1 country: China