Clinical trial NCT06225947: Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Keywords: insomnia
lemborexant
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
First posted: 2024-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with insomnia administered with LEM.

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.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years) and agreed to participate in the study, regardless of gender.
* Diagnosed with insomnia according to DSM-5.
* Insomnia Severity Index (ISI) score \>10.
* 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 ≥ 20.
* GAD-7 scores ≥ 15.
* 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.

Primary outcomes:
measure: Proportion of patients with insomnia remission
timeFrame: Baseline, week 1, week 2, week 4, week 12
Secondary outcomes:
measure: Retention rate of Lemborexant treatment at each visit
timeFrame: up to week 12
measure: Change from baseline of mean ISI score at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Change from baseline of mean ISI score at LEM 5mg and 10 mg at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Change from baseline of mean ISI score with LEM monotherapy, alternative therapy, and combination therapy at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Change from baseline of mean ISI score in patients with depression symptoms at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Proportion of insomnia treatment responders at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean ESS score at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean ESS score at LEM 5mg and 10mg at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean ESS score at age <55 and ≥ 55 at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean ESS score with LEM monotherapy, alternative therapy, and combination therapy at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean ESS score in patients with depression symptoms at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean QOL-BREF score at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean QOL-BREF score at LEM 5mg and 10mg at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean QOL-BREF score at age <55 and ≥ 55 at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean QOL-BREF score with LEM monotherapy, alternative therapy, and combination therapy at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean QOL-BREF score in patients with depression symptoms at each visit
timeFrame: Baseline, week 4, week 12
measure: Changes of mean PHQ-9 score at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean PHQ-9 score at LEM 5mg and 10mg at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean PHQ-9 score at age <55 and ≥ 55 at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean PHQ-9 score with LEM monotherapy, alternative therapy, and combination therapy at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean PHQ-9 score in patients with depression symptoms at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean GAD-7 score at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean GAD-7 score at LEM 5mg and 10mg at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean GAD-7 score at age <55 and ≥ 55 at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean GAD-7 score with LEM monotherapy, alternative therapy, and combination therapy at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Changes of mean GAD-7 score in patients with depression symptoms at each visit
timeFrame: Baseline, week 1, week 2, week 4, week 12
measure: Incidence of Treatment-Emergent Adverse Events during LEM treatment
timeFrame: Up to week 12
measure: Incidence of Serious Adverse Events during LEM treatment
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou United Family Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Clifford Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Fujun Jia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Bin Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: