Autism, Autism Spectrum Disorder
Conditions
Keywords
Diphenhdramine, Sleep, clinical trial, autism
Brief summary
The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Interventions
DRUGDiphenhydramine
25mg (and up to 50mg) Diphenhydramine given orally
DRUGPlacebo
Matching Placebo given orally
Sponsors
Stanford University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Participants will meet the following * Outpatients between 8 and 17 years of age at the 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) or the Childhood Autism Rating Scale, Second Edition (CARS-2). * Males and females * Availability of polysomnography (PSG) or 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 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).
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 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 benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines * history of hypersensitivity to diphenhydramine * history of severe side effects from diphenhydramine * history of adequate trial of diphenhydramine * current use of any medications known to interact with diphenhydramine such as medications inhibiting CYP2D6 * taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy | Baseline, Week 4 and Week 8 |
| Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG) | Baseline, Week 4 and Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy | Baseline, Week 4 and Week 8 |
Countries
United States
Contacts
CONTACTRyan Villacrucis
CONTACTRobin Libove
PRINCIPAL_INVESTIGATORAntonio Y. Hardan, MD
Stanford University
Outcome results
None listed