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临床试验/JPRN-jRCTs071220104
JPRN-jRCTs071220104进行中（未招募）Unknown

Efficacy and safety of Melatonin for sleep problems in infants, children and adolescents with neurodevelopmental disorders - Mel-moe study

Yamashita Yushiro0 个研究点目标入组 60 人开始时间: 2023年2月2日最近更新:
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适应症

试验速览

阶段
Unknown
状态
进行中（未招募）
发起方
入组人数
60
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 2age old 至 <= 18age old（—）
性别
All

入选标准

  • •Selection Criteria for Starting Screening Phase
  • •1) Patients who are between 2 and 18 years of age at the start of the screening period.
  • •2) Patients who meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnostic criteria for neurodevelopmental disorders (intellectual disability group, communication disorder group, autism spectrum disorder, attention deficit/hyperactivity disorder, focal learning disorder, motor disorder group or other neurodevelopmental disorder group)
  • •3) Patients whose average daily latency to fall asleep (time between bedtime and time of falling asleep) is at least 30 minutes for at least 3 months at the beginning of the screening period.
  • •4) Patients who have received sleep hygiene instruction and medication instruction during the study period, and have gained the understanding of their caregivers and the patients themselves according to their comprehension of what to keep in mind.
  • •5) Patients who cooperate with the caregiver's observation of the patient's sleep status and entry into the electronic sleep diary during the study period.
  • •6) Patients whose caregivers and patients are able to come to the hospital on a set schedule.
  • •7) Outpatients
  • •8) Patients who have obtained written consent from a surrogate (person who has parental authority over the patient, guardian, or other equivalent person) prior to participation in the study, and patients who have obtained consent or assent from the patient himself/herself according to his/her capacity to understand.
  • •Selection Criteria for Initiation of Dosing
  • •1) Patients whose latency to fall asleep is at least 30 minutes on at least 3 of the last 7 days of the screening period.
  • •2) Patients who adhere to the bedtime schedule established at the beginning of the screening period [bedtime of +-60 minutes is considered acceptable, and patients are eligible if they are outside the acceptable range on 3 or fewer days during the last 7 days of the screening period].
  • •3) Patients who have properly entered the electronic sleep diary [Patients shall be eligible if there are 3 or fewer days during the last 7 days of the screening period on which items related to sleep onset latency (bed time or time of sleep onset) were not entered].

排除标准

  • •Exclusion criteria for starting the screening phase
  • •1) Patients with a history of melatonin use (including Clozapine or supplements)
  • •2) Patients taking Ramelteon (melatonin receptor agonist) within 2 weeks prior to the start of the screening period.
  • •3) Patients with a history of hypersensitivity or allergy to Clozapine or any of the components of Ramelteon
  • •4) Patients with hepatic dysfunction
  • •5) Patients with schizophrenia or bipolar disorder
  • •6) Patients with sleep-related breathing disorders or sleep-related movement disorders
  • •7) Patients with obstructive ventilation disorders (bronchial asthma, adenoid hypertrophy, palatoglossal hypertrophy, etc.) that are being treated or require treatment
  • •8) Patients with asthma whose nocturnal symptoms (cough and dyspnea) are not well controlled.
  • •9) Patients with physical factors that interfere with sleep, such as pain, itching, or rhinitis, causing sleep disturbances.
  • •10) Patients with systemic conditions that interfere with the practice of sleep hygiene instruction (especially exercise during the day, etc.).
  • •11)Patients who are using concomitantly prohibited drugs (including over-the-counter drugs) within 2 weeks prior to the start of the screening period, or whose use during the study period is required [concomitantly prohibited drugs, with the exception of melatonin receptor agonists, may be used for sedation during tests (EEG, etc.)].
  • •12) Patients who have started using concomitantly restricted drugs (including OTC drugs) within 2 weeks prior to the start of the screening period or who require new use and dosage modification during the study period.
  • •13) Patients who are receiving cognitive behavioral therapy (CBT) or high-intensity light therapy for sleep disorders within 2 weeks prior to the start of the screening period or are scheduled to receive such therapy during the study period.
  • •14) Patients who are breastfeeding or receiving nighttime feeding for the purpose of sleep-restraint.
  • •15) Patients who are scheduled to stay overnight during the screening period.
  • •16) Patients who have received any investigational drug or post-marketing clinical trial drug (including placebo) within 4 months prior to the start of the screening period
  • •17) Patients participating in clinical research involving blood sampling or medical device clinical trials within 4 months prior to the start of the screening period
  • •18) Patients who are pregnant, may become pregnant, are planning to become pregnant, or are breast-feeding.
  • •19) Patients with other serious diseases or findings that the investigator (or subinvestigator) deems inappropriate for the subject of this study.
  • •Exclusion criteria at initiation of treatment
  • •1) Patients who do not meet the selection criteria or have any disease or findings that are judged by the Principal Investigator(s) to be in conflict with the exclusion criteria for initiation of the screening period, based on the interview, physical examination, or clinical examination after obtaining consent
  • •2) Patients who are using concomitantly prohibited medications (including over-the-counter drugs and, for melatonin, Clozapine or supplements) after the start of the screening period [concomitantly prohibited medications, except for melatonin receptor agonists, may be used for sedation during tests (EEG, etc.)].
  • •3) Patients who have started concomitantly restricted medications (including over-the-counter drugs) or have changed the dosage or administration of concomitantly restricted medicatio

研究者

发起方
Yamashita Yushiro

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