Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia
NCT ID: NCT06225947
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-02-22
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Lemborexant 5 MG
The recommended dosage of Lemborexant(LEM) is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.
Interventions
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Lemborexant 5 MG
The recommended dosage of Lemborexant(LEM) is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Fujun Jia, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Bin Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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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
Clifford Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2023-1072-02
Identifier Type: -
Identifier Source: org_study_id
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