RecruitingPhase 4NCT05599126

A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems

A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems


Sponsor

Zhenghui YI

Enrollment

300 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. However, whether mianserin can improve cognitive function in patients still needs to be explored. The benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. The mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with SSRI drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. Therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. To compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a medication called mianserin to standard antidepressants (SSRIs) helps people with major depression who also have sleep problems. Both depression and poor sleep reinforce each other, and researchers want to see if treating both at the same time leads to better outcomes. **You may be eligible if...** - You have been diagnosed with major depressive disorder and score in the moderate-to-severe range on depression and anxiety rating scales - You have sleep problems or score above 7 on a standard sleep quality questionnaire - You are of Han Chinese ethnicity, age 18-60 - You have completed at least junior high school education - You have not taken antidepressants or sleeping pills recently **You may NOT be eligible if...** - You have ever had a manic episode (suggesting bipolar disorder) - You have a history of psychosis or schizophrenia - You have serious heart, kidney, or liver disease - You are pregnant or breastfeeding 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

DRUGMianserin

Subjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime.

DRUGLorazepam

Subjects were required to take lorazepam regularly during the study period, with the effective dose being taken orally once a night before bedtime.


Locations(1)

Shanghai Mental Health Center

Shanghai, China

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NCT05599126


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