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Completed

NCT Number: NCT00927030

Melatonin for Sleep in Children With Autism

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).

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt Medical Center

Nashville, Tennessee, 37232-2551, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

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.

Other names: Natrol brand liquid melatonin

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.

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

Primary outcomes

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

    Time frame: Two Years from study start

Secondary outcomes

  1. A sub-set of 12 children will be studied to characterize the pharmacokinetic profile of orally administered melatonin.

    Time frame: 2 years from start of study

  2. A group of behavioral and parental stress measures will be piloted for the participants in this study.

    Time frame: 2 years from start of study

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Melatonin for Sleep in Children With Autism: Safety Tolerability and Dose

Acronym: NICHD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 24, 2009
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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