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A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Led by Shanghai Mental Health Center · Updated on 2026-02-18
121
Participants Needed
9
Research Sites
48 weeks
Total Duration
On this page
Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to evaluate the effectiveness and safety of lemborexant (a new dual orexin receptor antagonist) in the treatment of patients with mental disorders complicated with insomnia. The subjects are patients aged 18 years and above, who meet the DSM-5 diagnostic criteria for mental disorders and have an Insomnia Severity Index (ISI) score ≥11. They will receive lemborexant treatment for 8 weeks, with follow-up to observe the improvement of insomnia symptoms and adverse events, so as to provide real-world evidence for the clinical optimization of treatment regimens for insomnia comorbid with psychiatric disorders.
CONDITIONS
Official Title
A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above, regardless of gender
- Meet the DSM-5 diagnostic criteria for any mental disorder
- Have an Insomnia Severity Index (ISI) score of 11 or higher
- Have at least 7 hours of sleep time available
- Able to complete the 2-month scale assessment and follow-up plan
- Voluntarily sign the informed consent form
- Intend to receive lemborexant treatment as judged by clinicians
You will not qualify if you...
- Mental disorder is in the acute phase or psychotropic drug dose cannot be stabilized during the study
- Concurrent use of two or more benzodiazepine receptor agonists for insomnia
- Previous continuous use of dual orexin receptor antagonist drugs for more than 1 week
- Clear suicide attempt, plan, or high suicide risk
- Pregnant or lactating women
- Patients with narcolepsy
- Patients with severe liver failure
- Severe or unstable cardiovascular, respiratory, digestive, or other system diseases
- Other conditions deemed unsuitable for participation by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Suzhou GuangJi Hospital
Suzhou, Jiangsu, China, 215000
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2
Xuzhou Oriental People's Hospital
Xuzhou, Jiangsu, China, 221000
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3
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
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4
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120
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5
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, China, 200120
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6
Shanghai Fengxian District Mental Health Center
Shanghai, Shanghai Municipality, China, 201400
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7
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
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8
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
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9
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
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Research Team
W
Wenzheng Wang, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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