Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia
- Registration Number
- NCT06225947
- Lead Sponsor
- Guangdong Provincial People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lemborexant(LEM) Lemborexant 5 MG 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.
- Primary Outcome Measures
Name Time Method Proportion of patients with insomnia remission 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 Outcome Measures
Name Time Method Change from baseline of mean ISI score at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ISI score from baseline was defined as the average score of ISI scale at each visit relative to baseline. 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.
Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ISI score from baseline was defined as the average score of ISI scale at age \<55 and ≥ 55 at each visit relative to baseline. 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.
Retention rate of Lemborexant treatment at each visit up to week 12 The retention rate is defined as the percentage of participants remaining on Lemborexant treatment regardless of treatment pattern, starting from the first dose of study drug.
The retention is primarily defined as follows:
* Patients who wish to continue LEM treatment at each visit.
* Patients who wish to continue LEM treatment at each visit. but do not actually continue with a reason not related to the efficacy or safety of LEM treatment (including, but not limited to relocation, clinic transfer, or a burden of site visit expenses)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 of mean ISI score from baseline was defined as the average score of ISI scale in patients with depression symptoms at each visit relative to baseline.
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.
Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.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 of mean ISI score from baseline was defined as the average score of ISI scale at LEM 5mg and LEM 10mg at each visit relative to baseline. 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.
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 Change of mean ISI score from baseline was defined as the average score of ISI scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
* LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.
* Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.
* Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics.
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.Changes of mean ESS score at age <55 and ≥ 55 at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ESS score from baseline was defined as the average score of ESS scale at age \<55 and ≥ 55 at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.
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 Change of mean ESS score from baseline was defined as the average score of ESS scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
* LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.
* Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.
* Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics.
The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.Proportion of insomnia treatment responders at each visit Baseline, week 4, week 12 Responder was defined as total ISI reduction≥6 compared to baseline. 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.
Changes of mean ESS score in patients with depression symptoms at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ESS score from baseline was defined as the average score of ESS scale in patients with depression symptoms at each visit relative to baseline.
The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.
Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.Changes of mean QOL-BREF score at LEM 5mg and 10mg at each visit Baseline, week 4, week 12 Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at LEM 5mg and 10mg at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.
Changes of mean PHQ-9 score at age <55 and ≥ 55 at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at age \<55 and ≥ 55 at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.
Changes of mean GAD-7 score at age <55 and ≥ 55 at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at age \<55 and ≥ 55 at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.
Changes of mean QOL-BREF score at age <55 and ≥ 55 at each visit Baseline, week 4, week 12 Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at age \<55 and ≥ 55 at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.
Changes of mean PHQ-9 score in patients with depression symptoms at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale in patients with depression symptoms at each visit relative to baseline.
Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10.The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.Incidence of Serious Adverse Events during LEM treatment Up to week 12 Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)
Changes of mean ESS score at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ESS score from baseline was defined as the average score of ESS scale at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.
Changes of mean ESS score at LEM 5mg and 10mg at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean ESS score from baseline was defined as the average score of ESS scale at LEM 5mg and 10 mg at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.
Changes of mean QOL-BREF score at each visit Baseline, week 4, week 12 Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.
Changes of mean PHQ-9 score at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.
Changes of mean PHQ-9 score at LEM 5mg and 10mg at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at LEM 5mg and 10mg at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.
Changes of mean GAD-7 score at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.
Changes of mean QOL-BREF score in patients with depression symptoms at each visit Baseline, week 4, week 12 Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale in patients with depression symptoms at each visit relative to baseline.
QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.
Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.Changes of mean QOL-BREF score with LEM monotherapy, alternative therapy, and combination therapy at each visit Baseline, week 4, week 12 Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
* LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.
* Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.
* Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics.
QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.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 Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
* LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.
* Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.
* Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics.
The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.Changes of mean GAD-7 score at LEM 5mg and 10mg at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at LEM 5mg and 10mg at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.
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 Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.
* LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.
* Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.
* Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics.
The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.Changes of mean GAD-7 score in patients with depression symptoms at each visit Baseline, week 1, week 2, week 4, week 12 Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale in patients with depression symptoms at each visit relative to baseline.
The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.
Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.Incidence of Treatment-Emergent Adverse Events during LEM treatment Up to week 12 Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
Trial Locations
- Locations (5)
Clifford Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou United Family Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China