Phase 2 Autism Spectrum Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 8 and 17 years old who are seen as outpatients (not currently admitted to a hospital)
- People who have been diagnosed with Autism Spectrum Disorder (ASD) based on a clinical evaluation and confirmed using standard diagnostic tools
- Both males and females are eligible
- People for whom sleep monitoring data (either from an overnight sleep study or a wrist-worn movement tracker) is available
- People who have sleep problems, as shown by a score of 41 or higher on a standard sleep habits questionnaire for children
- People who have a caregiver who can reliably bring them to clinic visits, give accurate reports about them, and who spends regular time with them
- People whose medications have been at a stable dose for at least 2 weeks (or at least 4 weeks if they take Prozac/fluoxetine)
- People for whom no changes to their current treatments or therapies are planned during the trial
- People (and their caregivers) who are willing to provide saliva samples, attend safety check-ups at every visit, complete two overnight sleep studies (at weeks 4 and 8), and wear a wrist activity tracker for 2 weeks before the trial and throughout the 8 weeks of the trial
Who may not be able to join:
- People who are currently having thoughts of suicide, or who have a diagnosis of schizophrenia, schizoaffective disorder, or a psychotic disorder
- People with active medical conditions such as migraines, asthma, seizure disorder, or serious illness affecting the liver, kidneys, or heart
- People whose autism appears to be caused by a metabolic or infectious condition, based on medical history or test results
- Females who are pregnant or who are sexually active and not using a reliable form of contraception (pregnancy testing will be used in this study)
- People currently taking benzodiazepines, anti-seizure medications (when prescribed specifically for seizures or epilepsy), melatonin, or certain antihistamines that act on the brain
- People with a history of allergic reactions to diphenhydramine (a common antihistamine)
- People with a history of severe side effects from diphenhydramine
- People who have previously had a full course of treatment with diphenhydramine (confirm with trial site)
- People currently taking any medications known to interact with diphenhydramine, including certain drugs that affect how the body processes it (confirm with trial site)
- People currently taking anticholinergic medications (a type of drug that affects the nervous system, such as trihexyphenidyl or thioridazine)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Antonio Y. Hardan, MD, Stanford University
Phone: (650)736-1235
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy; Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.