Status:
RECRUITING
A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
RenJi Hospital
Shanghai Fengxian District Mental Health Center
Conditions:
Insomnia
Psychiatric Disorders
Eligibility:
All Genders
18+ years
Brief Summary
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 subjec...
Detailed Description
Background: The incidence of insomnia in patients with psychiatric disorder is as high as 70%-80%. Traditional benzodiazepine receptor agonists have risks such as addiction and cognitive impairment. L...
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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
Exclusion Criteria:
- Mental disorder is in the acute phase as judged by clinical assessment, or the dose of other psychotropic drugs cannot be stabilized during the study;
- Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs;
- Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for >1 week;
- Clear suicide attempt/plan or high suicide risk as judged by the researcher;
- Pregnant or lactating women;
- Patients with narcolepsy;
- Patients with severe hepatic insufficiency;
- Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems;
- Other conditions deemed unsuitable for participation by the researcher
Key Trial Info
Start Date :
January 24 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT07417813
Start Date
January 24 2026
End Date
December 31 2026
Last Update
February 18 2026
Active Locations (9)
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1
Suzhou GuangJi Hospital
Suzhou, Jiangsu, China, 215000
2
Xuzhou Oriental People's Hospital
Xuzhou, Jiangsu, China, 221000
3
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
4
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120