A Prospective, Multi-center, 3-month, Observational Study to Evaluate the Effectiveness and Safety of Lemborexant in Chinese Patients With Insomnia in Real World Setting.

Guangdong Provincial People's Hospital5 sites in 1 country200 target enrollmentFebruary 22, 2024

ConditionsInsomnia

InterventionsLemborexant 5 MG

DrugsLemborexant 5 MG

Overview

Phase: Not Applicable
Intervention: Lemborexant 5 MG
Conditions: Insomnia
Sponsor: Guangdong Provincial People's Hospital
Enrollment: 200
Locations: 5
Primary Endpoint: Proportion of patients with insomnia remission
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.

Detailed Description

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ISI ≥10, clinically judged to need pharmacological treatment will be enrolled.Patients will be administered with LEM, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment.

Registry

clinicaltrials.gov

Start Date

February 22, 2024

End Date

June 30, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Guangdong Provincial People's Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults (≥18 years) and agreed to participate in the study, regardless of gender.
•Diagnosed with insomnia according to DSM-
•Insomnia Severity Index (ISI) score \>
•Subjects who can guarantee at least 7 hours of bedtime.
•Subjects signed informed consent forms after the prescription.

Exclusion Criteria

•Beings unable to understand the questionnaire.
•PHQ-9 scores ≥
•GAD-7 scores ≥
•Suicidal thoughts/behaviors in the past one month or history of suicide, etc.
•Severe psychiatric disorder in the judgment of the investigator prevents completion of the trial.
•History of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject.
•According to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.).
•Other conditions not considered appropriate for participation by clinicians.

Arms & Interventions

Lemborexant(LEM)

Subjects will be administered with Lemborexant(LEM). The dosage of LEM is 5 mg or 10mg taken no more than once per night during the study.

Intervention: Lemborexant 5 MG

Outcomes

Primary Outcomes

Proportion of patients with insomnia remission

Time Frame: Baseline, week 1, week 2, week 4, week 12

Percentage of patients with total ISI score below 8 points after Lemborexant treatment. Insomnia remission is defined as total ISI below 8points. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 \~28. Higher score indicate worse severity.

Secondary Outcomes

Change from baseline of mean ISI score at each visit(Baseline, week 1, week 2, week 4, week 12)
Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit(Baseline, week 1, week 2, week 4, week 12)
Retention rate of Lemborexant treatment at each visit(up to week 12)
Change from baseline of mean ISI score in patients with depression symptoms at each visit(Baseline, week 1, week 2, week 4, week 12)
Change from baseline of mean ISI score at LEM 5mg and 10 mg at each visit(Baseline, week 1, week 2, week 4, week 12)
Change from baseline of mean ISI score with LEM monotherapy, alternative therapy, and combination therapy at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean ESS score at age <55 and ≥ 55 at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean ESS score with LEM monotherapy, alternative therapy, and combination therapy at each visit(Baseline, week 1, week 2, week 4, week 12)
Proportion of insomnia treatment responders at each visit(Baseline, week 4, week 12)
Changes of mean ESS score in patients with depression symptoms at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean QOL-BREF score at LEM 5mg and 10mg at each visit(Baseline, week 4, week 12)
Changes of mean PHQ-9 score at age <55 and ≥ 55 at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean GAD-7 score at age <55 and ≥ 55 at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean QOL-BREF score at age <55 and ≥ 55 at each visit(Baseline, week 4, week 12)
Changes of mean PHQ-9 score in patients with depression symptoms at each visit(Baseline, week 1, week 2, week 4, week 12)
Incidence of Serious Adverse Events during LEM treatment(Up to week 12)
Changes of mean ESS score at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean ESS score at LEM 5mg and 10mg at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean QOL-BREF score at each visit(Baseline, week 4, week 12)
Changes of mean PHQ-9 score at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean PHQ-9 score at LEM 5mg and 10mg at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean GAD-7 score at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean QOL-BREF score in patients with depression symptoms at each visit(Baseline, week 4, week 12)
Changes of mean QOL-BREF score with LEM monotherapy, alternative therapy, and combination therapy at each visit(Baseline, week 4, week 12)
Changes of mean PHQ-9 score with LEM monotherapy, alternative therapy, and combination therapy at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean GAD-7 score at LEM 5mg and 10mg at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean GAD-7 score with LEM monotherapy, alternative therapy, and combination therapy at each visit(Baseline, week 1, week 2, week 4, week 12)
Changes of mean GAD-7 score in patients with depression symptoms at each visit(Baseline, week 1, week 2, week 4, week 12)
Incidence of Treatment-Emergent Adverse Events during LEM treatment(Up to week 12)