Actively Recruiting
A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems
Led by Zhenghui YI · Updated on 2024-06-27
300
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
Z
Zhenghui YI
Lead Sponsor
R
Renhe Tang Pharmaceutical Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of major depressive disorder (DSM-5) with HAMD-17 score ≥ 17 and HAMA score ≥ 14
- Complaints of sleep problems or PSQI score > 7
- Han Chinese ethnicity, aged 18 to 60 years
- Education level of junior high school or above
- No history of manic episodes or mild manic manifestations
- No antidepressants or sedative-hypnotic use in the last 2 weeks or completed a 7-day washout if previously used
- No modified electroconvulsive therapy (MECT) in the last 8 weeks
- Voluntary participation with informed consent
You will not qualify if you...
- Organic mood disorders or psychiatric disorders related to physical illnesses or psychoactive substances
- Contraindications to escitalopram, mianserin, or lorazepam
- Family history of psychiatric or other somatic disorders
- Severe psychiatric symptoms that prevent completing interviews or understanding scales
- Pregnant or lactating women
- Inability to cooperate with study procedures effectively
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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