Insomnia Clinical Trials

Find Insomnia Clinical Trials Near You

A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety of Lemborexant on Insomnia Patients With Psychiatric Disorders

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai Fengxian District Mental Health Center
RECRUITING
Shanghai
Shanghai Mental Health Center
RECRUITING
Shanghai
Shanghai Pudong New Area Mental Health Center
RECRUITING
Shanghai
Suzhou GuangJi Hospital
RECRUITING
Suzhou
Xuzhou Oriental People's Hospital
RECRUITING
Xuzhou
Contact Information
Primary
Wenzheng Wang, PhD
fffty@163.com
18017311500
Time Frame
Start Date: 2026-01-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 121
Treatments
Lemborexant Treatment Group
All enrolled patients receive lemborexant treatment, with a study cycle of 8 weeks (including a baseline assessment period ≤1 week and an 8-week treatment observation period)
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, Shanghai Fengxian District Mental Health Center, RenJi Hospital, Suzhou Guangji Hospital, Xuzhou Oriental People's Hospital, First Affiliated Hospital of Ningbo University, Sir Run Run Shaw Hospital
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov