Trial of Zolpidem for Sleep in Children With Autism
Recruiting
Phase 2
Interventional Study
Autism
Autism Spectrum Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 8 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 26 (estimated)
- Sponsor
- Stanford University · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
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 evaluati…
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