drugset / Trial / NCT01780883

Melatonin Dose-effect Relation in Childhood Autism

NCT01780883

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-02
Primary completion
2013-07
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 2 mg Oral
Subject Melatonin Small molecule 4 mg Oral
Subject Melatonin Small molecule 10 mg Oral

Indications