NCT07417813 A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
| NCT ID | NCT07417813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Mental Health Center |
| Condition | Insomnia |
| Study Type | OBSERVATIONAL |
| Enrollment | 121 participants |
| Start Date | 2026-01-24 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 121 participants in total. It began in 2026-01-24 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years and above, regardless of gender; 2. Meet the DSM-5 diagnostic criteria for mental disorders (any type); 3. Insomnia Severity Index (ISI) score ≥11; 4. Have at least 7 hours of sleep time available; 5. Able to complete the 2-month scale assessment and follow-up plan; 6. Voluntarily sign the informed consent form; 7. Intend to receive lemborexant treatment as judged by the clinicians Exclusion Criteria: 1. 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; 2. Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs; 3. Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for \>1 week; 4. Clear suicide attempt/plan or high suicide risk as judged by the researcher; 5. Pregnant or lactating women; 6. Patients with narcolepsy; 7. Patients with severe hepatic insufficiency; 8. Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems; 9. Other conditions deemed unsuitable for participation by the researcher
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07417813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07417813 currently recruiting?
Yes, NCT07417813 is actively recruiting participants. Contact the research team at fffty@163.com for enrollment information.
Where is the NCT07417813 trial being conducted?
This trial is being conducted at Suzhou, China, Xuzhou, China, Shanghai, China, Shanghai, China and 5 additional locations.
Who is sponsoring the NCT07417813 clinical trial?
NCT07417813 is sponsored by Shanghai Mental Health Center. The trial plans to enroll 121 participants.
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