NCT06225947招募中不适用
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Proportion of patients with insomnia remission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Lemborexant 5 MG (Drug)
结局指标
主要结局
Proportion of patients with insomnia remission
时间窗: 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.
次要结局
- 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)
研究者
研究点 (5)
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