Melatonin for Sleep in Children With Autism

NCT00927030 | Completed Phase 1 DMC

• 1 other identifier: 071269
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Autistic Disorder; Insomnia

Keywords

Autism; children; sleep; insomnia

Outcome Measures

Primary Outcomes (1)

• Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism.

  Two Years from study start

Secondary Outcomes (2)

• 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

Study Arms (2)

Pharmacokinetic

EXPERIMENTAL

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.

Drug: supplemental liquid melatonin

flavored inert liquid

PLACEBO COMPARATOR

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.

Drug: flavored liquid or liquid supplemental melatonin

Interventions

supplemental liquid melatonin DRUG

Liquid melatonin will be given to the parent. There are 4 dose levels (1mg, 3mg, 6 mg, and 9mg)of melatonin that will be used at 3 week intervals. The child will start with 1mg and the dose will be increased at 3 week intervals until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. Once this goal is reached the child will stay on that dose through the remainder of the study.

Also known as: Natrol brand liquid melatonin

Pharmacokinetic

flavored liquid or liquid supplemental melatonin DRUG

Single blind for parents at initial 3-weeks dose period of 1 mg melatonin for 18 children where 3/18 children will receive placebo and 15/18 children will receive melatonin study drug. Each bottle will be labeled as: Flavored liquid placebo/or liquid melatonin. After this initial 3-week period all children will receive known melatonin in bottles that state this.

Also known as: Inert flavored liquid manufactored by PharmaCare in Mt. Juliet TN. A certificate of analysis is on file for this compounded liquid.

flavored inert liquid

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Vanderbilt Medical Center

Nashville, Tennessee, 37232-2551, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Beth A Malow, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Neurology and Pediatrics

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

US (1)