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
This trial does not accept healthy volunteersQualifiers
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 population
Adults ≥18 years with any DSM-5-diagnosed mental disorder, ISI score ≥11, ≥7 hours available sleep time, ability to complete 2-month assessments/follow-up, voluntary informed consent, and clinical indication for lemborexant treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lemborexant tablets
DrugLemborexant Tablets (Dayvigo® tablets 5 mg): Oral administration, taken before bedtime. The initial dose is 5mg/day, which can be adjusted to 10mg/day (maximum dose: 10mg/day) based on clinical response and tolerability. For patients using benzodiazepine receptor agonists(BZRAs) at baseline, it is recommended to gradually reduce and discontinue BZRAs within the first 4 weeks.
Treatment groups
121 Participants
are divided into 1 treatment groupGroup A: Lemborexant Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) Score from Baseline
Change in Insomnia Severity Index (ISI) Score from Baseline: Evaluated by the ISI scale (7 items, total score 0-28 points).
Time frame
Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatmentSecondary outcomes
1
ISI Treatment Response Rate
Proportion of patients with an ISI score decrease of ≥7 points from baseline.
Time frame
Measurement time points: Week 4 and Week 8 of treatment2
ISI Remission Rate
Proportion of patients with an ISI score \<8 points.
Time frame
Measurement time points: Week 4 and Week 8 of treatment3
Change in Sleep Satisfaction VAS Score
Including 3 dimensions (sleep onset efficiency, sleep maintenance, impact on daytime function) with 1-10 points for each dimension.
Time frame
Measurement time points: Baseline, Week 4 and Week 8 of treatment4
Change in Epworth Sleepiness Scale (ESS) Score
Change in Epworth Sleepiness Scale (ESS) Score: Total score 0-24 points.
Time frame
Measurement time points: Baseline, Week 4 and Week 8 of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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