Autistic Disorder, Insomnia
Conditions
Keywords
Autism, children, sleep, insomnia
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.
Interventions
DRUGsupplemental liquid melatonin
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.
DRUGflavored liquid or liquid supplemental melatonin
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism. | Two Years from study start |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed