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Recruiting NCT05501678

Trial of Diphenhydramine for Sleep in Children With Autism

Phase II Interventional Autism Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diphenhydramine, Placebo.
Who it may be relevant to
Registry conditions: Autism, Autism Spectrum Disorder. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Placebo-controlled Crossover Trial of Diphenhydramine for Sleep in Children With Autism

Overview

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

  • Drug Diphenhydramine
    25mg (and up to 50mg) Diphenhydramine given orally
  • Drug Placebo
    Matching Placebo given orally

Primary outcome measures

  • Change from baseline in sleep latency as measured by polysomnography (PSG) and/or actigraphy [Time frame: Baseline, Week 4 and Week 8]
  • Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG) [Time frame: Baseline, Week 4 and Week 8]
Secondary outcome measures (1)
  • Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy [Time frame: Baseline, Week 4 and Week 8]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT05501678 · IRB-66941 · 1P50HD109861

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗