MedTrace Logo

Melatonin Dose-effect Relation in Childhood Autism

NCT01780883 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

  • Childhood Autism

Interventions

DRUG

melatonin

DRUG

Placebo

Placebo tablets of Circadin®

Sponsors & Collaborators

  • Centre Hospitalier Guillaume Régnier, RENNES

    collaborator UNKNOWN

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Sylvie TORDJMAN, MD, PhD · Centre Hospitalier Guillaume Régnier, RENNES

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01780883 on ClinicalTrials.gov