Trial of Zolpidem for Sleep in Children With Autism

Официальное название

Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism

Обзор

The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Вмешательства

• Препарат Zolpidem
  5mg (and up to10mg) Diphenhydramine given orally
• Препарат Placebo
  Matching Placebo given orally

Первичные конечные точки

• Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM) [Срок оценки: Baseline, Week 4 and Week 8]

Вторичные конечные точки (1)

• Change from baseline in sleep efficiency as measured by actigraphy [Срок оценки: Baseline, Week 4 and Week 8]

Критерии участия

Критерии включения

Participants will meet the following

• Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1
• Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)
• Males and females
• Availability of polysomnography (PSG) and/or actigraphy data
• Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy.
• care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
• stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
• no planned changes in psychosocial and biomedical interventions during the trial
• willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial)
• requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Критерии исключения

Participants will be excluded if one or more of the following is met

• active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
• unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) and hepatic insufficiency
• evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism;
• pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
• individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, antidepressants, melatonin and centrally-acting antihistamines
• history of hypersensitivity to zolpidem
• history of severe side effects from zolpidem
• history of adequate trial of zolpidem
• current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
• history of complex sleep-related behaviors
• individuals using alcohol, marijuana and other substances.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT05540574 · IRB-67221 · 1P50HD109861

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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