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Идёт набор NCT07417813

A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders

— Наблюдательное Insomnia Psychiatric Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lemborexant tablets.
Кому может быть актуально
Состояния в реестре: Insomnia, Psychiatric Disorders. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

Background: The incidence of insomnia in patients with psychiatric disorder is as high as 70%-80%. Traditional benzodiazepine receptor agonists have risks such as addiction and cognitive impairment. Lemborexant was approved for marketing in China in 2025, but its real-world data in the population with insomnia comorbid with psychiatric disorder is insufficient. Hypothesis: 8-week treatment with lemborexant can significantly improve insomnia symptoms in insomnia comorbid with psychiatric disorders, with good safety. Design: A multicenter, prospective, single-arm, observational study. It is planned to enroll 121 patients (with an expected dropout rate of 30%), who will receive 8-week treatment. Efficacy will be evaluated by scales such as ISI and VAS, and adverse events will be monitored.

Вмешательства

  • Препарат Lemborexant tablets
    Lemborexant Tablets (Dayvigo® tablets 5 mg): Oral administration, taken before bedtime. The initial dose is 5mg/day, which can be adjusted to 10mg/day (maximum dose: 10mg/day) based on clinical response and tolerability. For patients using benzodiazepine receptor agonists(BZRAs) at baseline, it is recommended to gradually reduce and discontinue BZRAs within the first 4 weeks.

Первичные конечные точки

  • Change in Insomnia Severity Index (ISI) Score from Baseline [Срок оценки: Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment]
Вторичные конечные точки (7)
  • ISI Treatment Response Rate [Срок оценки: Measurement time points: Week 4 and Week 8 of treatment]
  • ISI Remission Rate [Срок оценки: Measurement time points: Week 4 and Week 8 of treatment]
  • Change in Sleep Satisfaction VAS Score [Срок оценки: Measurement time points: Baseline, Week 4 and Week 8 of treatment]
  • Change in Epworth Sleepiness Scale (ESS) Score [Срок оценки: Measurement time points: Baseline, Week 4 and Week 8 of treatment]
  • Lemborexant Treatment Retention Rate [Срок оценки: Week 4 and Week 8 of treatment]
  • BZRAs Discontinuation Rate [Срок оценки: Measurement time points: Week 4 and Week 8 of treatment]
  • BZRAs Dose Change [Срок оценки: Measurement time points: Week 4 and Week 8 of treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Mental disorder is in the acute phase as judged by clinical assessment, or the dose of other psychotropic drugs cannot be stabilized during the study;
  • Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs;
  • Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for >1 week;
  • Clear suicide attempt/plan or high suicide risk as judged by the researcher;
  • Pregnant or lactating women;
  • Patients with narcolepsy;
  • Patients with severe hepatic insufficiency;
  • Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems;
  • Other conditions deemed unsuitable for participation by the researcher

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 9 центров
  • Suzhou GuangJi Hospital — Сучжоу
  • Xuzhou Oriental People's Hospital — Xuzhou
  • Shanghai Mental Health Center — Шанхай
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
  • Shanghai Pudong New Area Mental Health Center — Шанхай
  • Shanghai Fengxian District Mental Health Center — Шанхай
  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Ханчжоу
  • The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу
  • … и ещё 1 центр

Идентификаторы

NCT: NCT07417813 · MZhao-025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗