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Melatonin for Autism

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
Male and female subjects with ASD
Be younger than 65 years old
Screening 3 weeks
Treatment Varies
Follow Up five nights of sleep over two weeks
Awards & highlights
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Both boys and girls with Autism Spectrum Disorder (ASD).


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep spindle density
Secondary outcome measures
Change in sleep quality

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Daytime drowsiness
Blurred vision
Study treatment Arm

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,896 Previous Clinical Trials
13,174,956 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,094 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

Frequently Asked Questions

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

Is the research program open to elderly individuals aged 85 and over?

"This trial seeks to enrol participants aged between 12 and 18. There are 225 trials available for people below the age of majority, while 42 exist specifically for those over 65 years old."

Answered by AI

Is this research study presently recruiting participants?

"Yes, the information hosted on clinicaltrials.gov attests to this trial's active recruitment process which began January 1st 2023 and was last updated February 7th 2023. The study is searching for 30 participants in one medical centre."

Answered by AI

Am I an appropriate candidate for this research endeavor?

"30 male and female patients with a diagnosis of Autism Spectrum Disorder between the ages 12-18, who can comprehend and reply to English language questionnaires will be admitted into this trial."

Answered by AI

What is the overall cohort size of participants involved in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first announced on January 1st 2023, is actively recruiting participants. 30 patients need to be gathered from a single medical site."

Answered by AI
~14 spots leftby Feb 2025