Melatonin for Sleep in Children With Autism

Insomnia Clinical Trial

— NICHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927030
• Other study ID #: 071269
• Status: Completed
• Phase: Phase 1
• First received: June 22, 2009
• Last updated: June 28, 2012
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Insomnia

Intervention

Drug:
• supplemental 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.
• flavored 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.

Locations

Country	Name	City	State
United States	Vanderbilt Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism.		Two Years from study start	Yes
Secondary	A sub-set of 12 children will be studied to characterize the pharmacokinetic profile of orally administered melatonin.		2 years from start of study	No
Secondary	A group of behavioral and parental stress measures will be piloted for the participants in this study.		2 years from start of study	No