Melatonin for Sleep in Children With Autism

Phase 1

Completed

• Conditions: Autistic Disorder; Insomnia
• Interventions: Drug: supplemental liquid melatonin; Drug: flavored liquid or liquid supplemental melatonin

• Registration Number: NCT00927030
• Lead Sponsor: Vanderbilt University

Brief Summary

The purpose of this study is to determine if liquid supplemental melatonin is an effective treatment for children with autism who have sleep problems related to insomnia (difficulty falling asleep).

Detailed Description

Sleep difficulties in children with autism spectrum disorders (ASD) are common reasons why parents seek medical intervention for their children. Identifying a safe and effective pharmacologic agent that promotes sleep in ASD would favorably impact the lives of these children and their families. In this study we plan to determine the dose-response, tolerability and any adverse effects of supplemental melatonin in 30 children with ASD.The melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. After a 3 week baseline period, the child will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling asleep within 30 minutes of bedtime at least 5/7 nights per week. No child will take more than 9 mg of supplemental melatonin.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Primary Completion: 2010-04
• Study Completion: 2010-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Children with autism ages 4-10 years.
• Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS).
• Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months.
• Children may take seasonal allergy medications.
• Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal.

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Exclusion Criteria

• Children taking medications other than those in the inclusion criteria.
• Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing).
• Children with non-febrile unprovoked epileptic seizure within the last two years.
• Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children.
• Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms.
• Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis.
• Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol.
• Tanner staging beyond level 1 at any time point in the study.
• Children whose assessment score does not place them on the autism spectrum.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic	supplemental liquid melatonin	We hope to target 12 of the 30 children to be enrolled for this study to participate in a pharmacokinetic arm of the study. These 12 children would be receiving overnight sleep studies prior to receiving the first dose of melatonin and again at about every 3 week intervals each time the dose increases until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. During the sleep studies an intravenous catheter will be placed in the child's arm to sample small amounts of blood throughout the day (about 3 teaspoons of blood)to allow us to look at how melatonin is produced in children with autism who have sleep problems.
flavored inert liquid	flavored liquid or liquid supplemental melatonin	Of the 30 targeted participants, 18 will be randomized at the first three week dosing period {1mg of melatonin}. The randomization will be single blind to the parent in a 5:1 ratio (15 children will receive melatonin, and 3 children will receive a flavored placebo at the first 3-week period only). After the initial 3-week dose cycle of 1 mg, all children randomized to placebo will begin 3 mg of melatonin and will continue in dose increase (6mg, 9 mg)until they meet the criteria of falling asleep within 30 minutes of bedtime 5/7 nights per week. No child will take more than 9 mg.

Primary Outcome Measures

Name	Time	Method
Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism.	Two Years from study start

Secondary Outcome Measures

Name	Time	Method
A sub-set of 12 children will be studied to characterize the pharmacokinetic profile of orally administered melatonin.	2 years from start of study
A group of behavioral and parental stress measures will be piloted for the participants in this study.	2 years from start of study

Trial Locations

Locations (1)

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States