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:

  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

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

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

A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders | DecenTrialz