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Melatonin for Autism

N/A
Recruiting
Led By Dara Manoach, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five nights of sleep over two weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how disrupted communication between the thalamus and cortex affects sleep, attention, and sensory sensitivities in children with autism. Sleep spindles provide a noninvasive way to assess this. Melatonin's effect on sleep spindles will also be examined.

Who is the study for?
This trial is for English-speaking children aged 12-18 with Autism Spectrum Disorder who can understand and respond to questionnaires. It's not suitable for those pregnant, breastfeeding, with sleep-affecting medical conditions, severe head injuries, IQ below 70, other neurological disorders including seizures, diagnosed sleep disorders or genetic causes of ASD.
What is being tested?
The study tests if melatonin improves the quality of sleep in autistic children by increasing a specific brain rhythm called 'sleep spindles'. The research aims to link better sleep and sensory processing with increased activity in a part of the brain involved in communication between its deep structures and outer layer.
What are the potential side effects?
Melatonin is generally considered safe but may cause side effects like drowsiness during waking hours, headaches or dizziness. Since it's commonly used as a sleep aid already, more serious side effects are rare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five nights of sleep over two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and five nights of sleep over two weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in sleep spindle density
Secondary study objectives
Change in sleep quality

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MelatoninExperimental Treatment1 Intervention
5mg melatonin gummy 30 min before bedtime for 2 consecutive nights
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,781 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,070 Patients Enrolled for Autism Spectrum Disorder
Dara Manoach, PhDPrincipal InvestigatorProfessor
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Melatonin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05716906 — N/A
Autism Spectrum Disorder Research Study Groups: Melatonin
Autism Spectrum Disorder Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05716906 — N/A
Melatonin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05716906 — N/A
~6 spots leftby Jun 2025
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