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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50HD109861 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant, then Placebo | Experimental | Participants will first receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. Participants will then receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. |
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| Placebo, then Suvorexant | Experimental | Participants will first receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. Participants will then receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | 5 mg (and up to 20 mg) Suvorexant given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM) | Baseline, Week 4 and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sleep efficiency as measured by actigraphy | Baseline, Week 4 and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion criteria:
Participants will meet the following
Exclusion criteria:
Participants will be excluded if one or more of the following is met
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Villacrucis | Contact | (650) 736-1235 | acesleepstudy@stanford.edu | |
| Robin Libove | Contact | (650) 736-1235 | rlibove@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Y. Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305-5719 | United States |
We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Placebo | Drug | Matching Placebo given orally |
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| 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 |