Melatonin for Sleep in Children With Autism

Completed · Phase 1 · Has a placebo group

Conditions studied: Autistic Disorder, Insomnia

In brief

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).

Key facts

Study ID

NCT00927030

Run by

Vanderbilt University

People needed

17

Starts

2008-01-01

Expected to finish

2010-10-01

Last updated by the study team

2012-07-02

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

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 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.

Where it is running

• Vanderbilt Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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