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A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety 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
17 weeks
Total Duration
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Sponsors
S
Shanghai Mental Health Center
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of lemborexant, a new dual orexin receptor antagonist, in treating adults with mental disorders complicated by insomnia. This observational study focuses on patients aged 18 and above who meet the DSM-5 criteria for mental disorders and have an Insomnia Severity Index score of 11 or higher. The study aims to provide real-world evidence for optimizing treatment plans for insomnia alongside psychiatric conditions. Participants will receive lemborexant tablets taken orally before bedtime, starting at 5 mg per day, which may be increased to 10 mg based on clinical response and tolerance. The treatment period lasts 8 weeks, including a baseline assessment week and 8 weeks of active treatment. Patients who are using benzodiazepine receptor agonists at the start are recommended to gradually reduce and stop these within the first 4 weeks. The study is single-arm and prospective, with all participants receiving lemborexant. During the study, participants will complete various assessments including the Insomnia Severity Index, Sleep Satisfaction VAS, and Epworth Sleepiness Scale at baseline, week 4, and week 8. Researchers will monitor changes in insomnia symptoms, treatment retention, benzodiazepine discontinuation rates, dose adjustments, and adverse events. The total duration of participation is approximately 8 weeks, with follow-up to observe symptom improvement and safety outcomes.
CONDITIONS
Brief 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 mental disorders (any type)
- Insomnia Severity Index (ISI) score 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 the 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 2 or more types of benzodiazepine receptor agonists as insomnia treatment
- 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive lemborexant tablets for insomnia with psychiatric disorders, with dose adjustments based on clinical response and tolerability. Those using benzodiazepine receptor agonists at baseline are recommended to gradually discontinue these within the first 4 weeks.
Visits at baseline, Week 4, and Week 8 for assessments
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
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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