A Phase 2 interventional study of melatonin and Placebo in Childhood Autism, sponsored by Rennes University Hospital. Completed at 4 sites in France. Open to male participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Rennes University Hospital · Phase 2, Interventional, and Treatment
Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion.
Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder.
These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.
The hormone melatonin is of interest in autism due to theoretical considerations and reports of altered melatonin production in individuals with autism. Melatonin produced in the pineal gland helps regulate human circadian rhythms including sleep-wake, and is considered as the best measure of circadian rhythms.
Several studies revealed that plasmatic and urinary nocturnal levels of melatonin are significantly lower in individuals with autism (in particular, in prepubertal children) compared to typically developing individuals. In addition, this reduction in nocturnal melatonin was significantly associated with the severity of communication and social interaction impairments, especially in verbal communication and play. Finally, diurnal excretion of melatonin was also found to be decreased in individuals with autistic disorder.
Given these results, administration of melatonin could serve, at least in prepubertal children wih autism, to normalize physiological, developmental and behavioral processes that are influenced by this pineal hormone. A randomized clinical trial is therefore necessary to establish potential therapeutic efficacy of melatonin in autistic disorder and to specify its dose-effect relation. This is the first clinical trial studying the melatonin dose-effect in autism.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's enrollment of 34 is below the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non-inclusion Criteria:
5 tablets of placebo once a day, an hour before falling asleep, for 6 weeks.
Drug: Placebo
1 tablet of 2mg melatonin and 4 tablets of its placebo once a day, an hour before falling asleep, for 6 weeks.
Drug: melatonin · Drug: Placebo
2 tablets of 2mg melatonin and 3 tablets of its placebo once a day, an hour before falling asleep, for 6 weeks.
Drug: melatonin · Drug: Placebo
5 tablets of 2mg melatonin once a day, an hour before falling asleep, for 6 weeks.
Drug: melatonin
Also known as: Circadin®
Placebo tablets of Circadin®
Severity of autistic disorder
Time frame: 6 weeks after the beginning of the treatment.
Severity of autistic impairments
Severity of autistic impairments (global severity of autistic disorder and anxiety) using the ADOS (Autism Diagnostic Observation Scale)
Time frame: 3 weeks after the beginning of the treatment
Sleep problems
Sleep problems will be assessed using a parental questionnaire and an actimetry sensor in the child recording
Time frame: 3 weeks after the beginning of the treatment
Excretion of the urinary metabolite of melatonin
Diurnal and nocturnal excretion of the urinary metabolite of melatonin (6-Sulphatoxymelatonin)
Time frame: 3 weeks after the beginning of the treatment
Severity of autistic impairments
Severity of autistic impairments (global severity of autistic disorder and anxiety) using the ICG scale
Time frame: 3 weeks after the beginning of the treatment
Severity of autistic impairments
Severity of autistic impairments (global severity of autistic disorder and anxiety) using the ADOS (Autism Diagnostic Observation Scale)
Time frame: 6 weeks after the beginning of the treatment
Sleep problems
Sleep problems will be assessed using a parental questionnaire and an actimetry sensor in the child recording
Time frame: 6 weeks after the beginning of the treatment
Excretion of the urinary metabolite of melatonin
Diurnal and nocturnal excretion of the urinary metabolite of melatonin (6-Sulphatoxymelatonin)
Time frame: 6 weeks after the beginning of the treatment
Severity of autistic impairments
Severity of autistic impairments (global severity of autistic disorder and anxiety) using the ICG scale
Time frame: 6 weeks after the beginning of the treatment
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Melatonin