A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Mental Health Center
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Lemborexant tablets
Treatment groups
121 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanghai Mental Health Center
Lead sponsor
RenJi Hospital
Collaborator
Shanghai Fengxian District Mental Health Center
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Xuzhou Oriental People's Hospital
Collaborator
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Collaborator
Suzhou Guangji Hospital
Collaborator
Source ClinicalTrials.gov