Melatonin Dose-effect Relation in Childhood Autism
Condition: Childhood Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets of Circadin®
Other intervention name(s): Circadin®
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: melatonin; childhood autism; 6-Sulphatoxymelatonin; autistic disorder; dose-effect relation