Trial of Suvorexant for Sleep in Children With Autism

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05546554

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Arms

55.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Autism Spectrum Disorder	Drug: Suvorexant Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suvorexant, then Placebo Participants will first receive Suvorexant for a 4-week period. A 5 mg dose of Suvorexant will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached.	Drug: Suvorexant 5 mg (and up to 20 mg) Suvorexant given orally Other Names: Belsomra Drug: Placebo Matching Placebo given orally
Experimental: Placebo, then Suvorexant Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached. Participants will then receive Suvorexant for a 4-week period. A 5 mg dose of Suvorexant will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached.	Drug: Suvorexant 5 mg (and up to 20 mg) Suvorexant given orally Other Names: Belsomra Drug: Placebo Matching Placebo given orally

Arm

Intervention/Treatment

Experimental: Suvorexant, then Placebo

Participants will first receive Suvorexant for a 4-week period. A 5 mg dose of Suvorexant will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached.

Drug: Suvorexant

5 mg (and up to 20 mg) Suvorexant given orally

Other Names:

Belsomra

Drug: Placebo

Matching Placebo given orally

Experimental: Placebo, then Suvorexant

Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached. Participants will then receive Suvorexant for a 4-week period. A 5 mg dose of Suvorexant will be given at bedtime for one week and then will increase by 5 mg if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg is reached.

Drug: Suvorexant

5 mg (and up to 20 mg) Suvorexant given orally

Other Names:

Belsomra

Drug: Placebo

Matching Placebo given orally

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale scores [Baseline, Week 4 and Week 8]
Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores [Baseline, Week 4 and Week 8]
Change from baseline on Parent Sleep Habits Questionnaire Parent (PSHQ) scores [Baseline, Week 4 and Week 8]
Change from baseline on Clinical Global Impression Scale (CGI) scores [Baseline, Week 4 and Week 8]
Change from baseline on Child Behavior Checklist (CBCL) scores [Baseline, Week 4 and Week 8]
Change from baseline on Social Responsiveness Scale, Second Edition (SRS-2) scores [Baseline, Week 4 and Week 8]
Change from baseline on Repetitive Behavior Scale - Revised (RBS-R) scores [Baseline, Week 4 and Week 8]
Change from baseline on Sensory Profile Questionnaire (SPQ) scores [Baseline, Week 4 and Week 8]
Change from baseline on Stanford Social Dimension Scale (SSDS) scores [Baseline, Week 4 and Week 8]
Change from baseline on Dimensional Assessment of Repetitive Behaviors (DARB) score [Baseline, Week 4 and Week 8]
Change from baseline on NEuroPSYchological Assessment, 2nd Edition (NEPSY-2) Affect Recognition scores [Baseline, Week 4 and Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

Participants will meet the following

Outpatients between 8 and 17 years of age
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
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 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., PSG and actigraphy at week 4 and 8, and safety measurements every visit).

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)
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, serotonin selective re-uptake inhibitors, 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