Status:
COMPLETED
Melatonin for Sleep in Children With Autism
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autistic Disorder
Insomnia
Eligibility:
All Genders
4-10 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00927030
Start Date
January 1 2008
End Date
October 1 2010
Last Update
July 2 2012
Active Locations (1)
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1
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2551