Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

Last updated: July 29, 2024
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Lemborexant 5 MG

Clinical Study ID

NCT06225947
KY2023-1072-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 completionof the trial.

  • History of serious illness, mental illness, medication use, and uncontrolled poorsleep habits that the investigator believes interfere with the study evaluation orthe safety of the subject.

  • According to the precautions listed in the instructions, there are anycontraindications or other conditions for which the use is prohibited (such asnarcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.).

  • Other conditions not considered appropriate for participation by clinicians.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Lemborexant 5 MG
Phase:
Study Start date:
February 22, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Clifford Hospital

    Guangzhou, Guangdong 511400
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Guangzhou United Family Hospital

    Guangzhou, Guangdong 510335
    China

    Active - Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

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