Does Melatonin Restore Sleep Architecture in Autistic Children

NCT01993251 | Completed Phase 2 DMC

• 2 other identifiers: 2012-7322013-001230-17
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation. Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders. Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders. It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings). The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects. The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.

Conditions

Sleep Disorders

Keywords

sleep,melatonin,autism,children

Outcome Measures

Primary Outcomes (1)

• To determine the most effective dose of melatonin to improve sleep quality in autistic children.

  The primary outcome is to measure the awakenings index which is the number of nocturnal awakenings higher than 15 seconds per hour of sleep measured by polysomnography.

  The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography.

Secondary Outcomes (9)

• To assess in autistic children the melatonin effects on sleep characteristics

  It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

• To assess the effectiveness of treatment on sleep disorders.

  It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

• To assess the effectiveness of melatonin on daytime autistic behavior

  It will be assessed three times at V1 (D0), V2 (D29 +/- 7 days) and V4 (D44+/-7days).

• To assess the melatonin safety in autistic children.

  It will be assessed three times at V2 (D29 +/- 7 days), V3(D30) and V4 (D44+/-7days).

• Establish whether there is a correlation between sleep quality and melatonin secretion.

  It will be assessed twice at V3 (D30) and V4 (D44+/-7days).

Study Arms (4)

melatonin 0.5mg

ACTIVE COMPARATOR

Drug: melatonin

melatonin 2mg

ACTIVE COMPARATOR

Drug: Melatonin

melatonin 6mg

ACTIVE COMPARATOR

Drug: Melatonin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Melatonin DRUG

one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime

melatonin 0.5mg

placebo DRUG

one capsule, placebo, oral, once a day, 30 minutes before bedtime

placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls from 3 to 12 years old with autism spectrum,
• Diagnosed by psychiatrists according to the diagnostic criteria for autism ICD-10 AND ADI or ADOS positive,
• With trouble sleeping, assessed by questionnaire CHSQ,
• Having made a night polysomnography,
• Written informed consent (signed by parents),
• Affiliated with the French universal healthcare system.

You may not qualify if:

• Children who stopped all treatment for sleep for less than one month,
• Liver or kidney insufficiencies,
• Acute illness during or occurred in the month preceding the study,
• Neurological disease without autism spectrum , patients with non-controlled epilepsy
• Health background witch can influence sleep (other than autism itself),
• Obstructive syndrome (history - oral breathing in wakefulness, nocturnal snoring significant (heard the door closed), nocturnal respiratory effort, apnea reported by parents- and clinical examination (chronic nasal congestion, large tonsils and touching),
• Known hypersensitivity to the active substance or to one of the excipient contained in the verum or in the placebo,
• Children under treatment against-indicated with the study treatment witch can't be stopped

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Hôpital Femme Mere Enfant

Bron, 69677, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Hospitalier du Chinonais

Chinon, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (1)

• Effects of immediate melatonin on sleep and behavior in children with autism SOMELIA study Guyon A, Comajuan M, Limousin N, Trippi, Schröder C, Plancoulaine S, Franco P The 21st International Congress of the ESCAP - Beyond nature & nurture Strasbourg, France, 29/06/2025 - 01/07/2025

  BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Patricia Franco, MD

  CHU Hôpital Femme Mère Enfant.Bron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: June 1, 2014
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)