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Antihistamine

Diphenhydramine for Sleep in Children with Autism

Phase 2
Recruiting
Led By Antonio Y. Hardan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, and week 8
Awards & highlights

Study Summary

This trial will examine the effect of an anti-histamine on sleep in children & adolescents with ASD, using 8-week randomized double-blind placebo-controlled study design.

Who is the study for?
This trial is for children and adolescents aged 8-17 with Autism Spectrum Disorder who have sleep disturbances. They must be outpatients with stable medications, not planning any treatment changes during the study, and able to provide saliva samples. Those with certain medical conditions or on conflicting medications cannot participate.Check my eligibility
What is being tested?
The trial tests if Diphenhydramine improves sleep in kids with autism using a double-blind method where neither doctors nor participants know who gets the real medicine or placebo. It's an 8-week study comparing drug effects to a fake pill (placebo) using sleep tracking and safety checks.See study design
What are the potential side effects?
Diphenhydramine may cause drowsiness, dry mouth, constipation, blurred vision, or dizziness. In some cases, it can lead to more serious side effects like heart palpitations or allergic reactions but these are less common.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in duration of non-rapid eye movement (NREM) sleep as measured by polysomnography (PSG)
Change from baseline in sleep latency as measured by polysomnography (PSG)
Secondary outcome measures
Change from baseline in sleep efficiency as measured by polysomnography (PSG) and actigraphy
Other outcome measures
Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores
Change from baseline on Child Behavior Checklist (CBCL) scores
Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale scores
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, then DiphenhydramineExperimental Treatment2 Interventions
Participants will first receive Placebo (fake tablet) for a 4-week period. A 25 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated. Participants will then receive Diphenhydramine for a 4-week period. A 25 mg dose of Diphenhydramine will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated.
Group II: Diphenhydramine, then PlaceboExperimental Treatment2 Interventions
Participants will first receive Diphenhydramine for a 4-week period. A 25 mg dose of Diphenhydramine will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 25 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 50 mg if needed and if well tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Diphenhydramine
2002
Completed Phase 4
~1170

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,824 Total Patients Enrolled
20 Trials studying Autism Spectrum Disorder
2,420 Patients Enrolled for Autism Spectrum Disorder
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,324 Total Patients Enrolled
33 Trials studying Autism Spectrum Disorder
4,071 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
425 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
377 Patients Enrolled for Autism Spectrum Disorder

Media Library

Diphenhydramine (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT05501678 — Phase 2
Autism Spectrum Disorder Research Study Groups: Diphenhydramine, then Placebo, Placebo, then Diphenhydramine
Autism Spectrum Disorder Clinical Trial 2023: Diphenhydramine Highlights & Side Effects. Trial Name: NCT05501678 — Phase 2
Diphenhydramine (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501678 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Diphenhydramine a risk to those taking it?

"With Phase 2 trials attesting to its safety, Diphenhydramine was given a score of 2 for this evaluation. No data has been gathered yet on the efficacy of it as an intervention."

Answered by AI

What is the aggregate number of participants in this experiment?

"Affirmative. Clinicaltrials.gov displays that this research is actively seeking volunteers, having been first published on July 12th 2023 and last edited on the 13th of the same month. The trial needs to find 26 participants from 1 medical site."

Answered by AI

Does this experiment encompass octogenarians?

"This clinical trial has specific criteria for eligible participants, which state that those aged 8 to 17 are able to apply. There are 260 studies available for minors and 57 trials designated for seniors beyond the age of 65."

Answered by AI

Are there any vacancies for prospective participants in this experiment?

"Clinicaltrials.gov indicates that this clinical trial is presently recruiting participants, with the initial posting of the study occuring on July 12th 2023 and its most recent update having taken place on July 13th 2023."

Answered by AI

Is there an opportunity to become involved in this research study?

"For this clinical trial, scientists seek 26 individuals between the ages of 8 and 17 who present with autism. Furthermore, patients must conform to DSM-5 criteria for Autism Spectrum Disorder (ASD), possess polysomnography or actigraphy data, show signs of sleep disturbance through a score on the CSHQ higher than 41, have had stable medications for at least one month prior to enrollment in the study, not anticipate any changes to their psychosocial/biomedical interventions during the course of the experiment, provide additional saliva samples as needed throughout testing ,and be willing to participate in all key procedures associated with trialling (PSG"

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trial of Diphenhydramine for Sleep in Children With Autism
Antonio Hardan 2023. "Trial of Diphenhydramine for Sleep in Children With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501678.
~17 spots leftby Dec 2026
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