Trial of Suvorexant for Sleep in Children With Autism
Trial ID or NCT#
NCT05546554
Status
RECRUITING
Purpose
The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Official Title
Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism
Eligibility Criteria
Ages Eligible for Study: 13 to 17
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- Participants will meet the following
- * Outpatients between 13 and 17 years of age at time of consent* 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)* Males and females* Availability of polysomnography (PSG) and 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* 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).
- Exclusion criteria:
- Participants will be excluded if one or more of the following is met
- * active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder* active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), obstructive sleep apnea and severe hepatic insufficiency* evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), 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 and chromosomal analysis* pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)* individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin and antihistamines* history of hypersensitivity to suvorexant* history of severe side effects from suvorexant* history of adequate trial of suvorexant* current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A* history of narcolepsy
Exclusion Criteria:
- Participants will be excluded if one or more of the following is met
- * active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder* active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), obstructive sleep apnea and severe hepatic insufficiency* evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), 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 and chromosomal analysis* pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)* individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin and antihistamines* history of hypersensitivity to suvorexant* history of severe side effects from suvorexant* history of adequate trial of suvorexant* current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A* history of narcolepsy
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Ryan Villacrucis
(650) 736-1235
View on ClinicalTrials.gov
