Melatonin for Autism

Phase-Based Progress Estimates
Massachusetts General Hospital, Boston, MAAutism+1 MoreMelatonin - DietarySupplement
12 - 18
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Autism

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Five nights of sleep over two weeks

Five nights of sleep over two weeks
Change in sleep quality
Change in sleep spindle density

Trial Safety

Safety Progress

1 of 3

Side Effects for

39%Early Morning Wakening
36%Daytime drowsiness
11%Blurred vision
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01114373) in the Melatonin ARM group. Side effects include: Fatigue with 42%, Early Morning Wakening with 39%, Daytime drowsiness with 36%, Dizziness with 11%, Blurred vision with 11%.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Melatonin · No Placebo Group · N/A

Experimental Group · 1 Intervention: Melatonin · Intervention Types: DietarySupplement
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: five nights of sleep over two weeks

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,730 Previous Clinical Trials
31,213,694 Total Patients Enrolled
Dara Manoach, PhDPrincipal InvestigatorProfessor
2 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 12 - 18 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Both male and female individuals with autism spectrum disorder.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Is this research study presently recruiting participants?

"Yes, the information hosted on 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.