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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five nights of sleep over two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five nights of sleep over two weeks
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 • NCT0111437342%
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
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
2,955 Previous Clinical Trials
13,212,648 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,098 Patients Enrolled for Autism Spectrum Disorder
Dara Manoach, PhDPrincipal InvestigatorProfessor
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have long-term health conditions that make it difficult for you to sleep.You have had a serious head injury in the past that caused you to lose consciousness for a long time or have ongoing neurological problems.Your IQ score is less than 70.You have a different neurological disorder, like epilepsy or seizures.You have been diagnosed with a sleep disorder.You are currently taking melatonin or have had a bad reaction to it in the past.Both boys and girls with Autism Spectrum Disorder (ASD).You have used drugs or alcohol excessively in the past six months, except for nicotine.You have a long-term medical condition that is not well-controlled or stable, like asthma, diabetes, cystic fibrosis, or heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Melatonin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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