Trial record 6 of 434 for: pharmacology + NICHD

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Melatonin for Sleep in Children With Autism (NICHD)

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Beth Ann Malow, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00927030

First received: June 22, 2009

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Purpose

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).

Condition	Intervention	Phase
Autistic Disorder Insomnia	Drug: supplemental liquid melatonin Drug: flavored liquid or liquid supplemental melatonin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment
Official Title:	Melatonin for Sleep in Children With Autism: Safety Tolerability and Dose

Resource links provided by NLM:

MedlinePlus related topics: Autism Sleep Disorders

Drug Information available for: Melatonin

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism. [ Time Frame: Two Years from study start ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	January 2008
Study Completion Date:	October 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pharmacokinetic We hope to target 12 of the 30 children to be enrolled for this study to participate in a pharmacokinetic arm of the study. These 12 children would be receiving overnight sleep studies prior to receiving the first dose of melatonin and again at about every 3 week intervals each time the dose increases until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. During the sleep studies an intravenous catheter will be placed in the child's arm to sample small amounts of blood throughout the day (about 3 teaspoons of blood)to allow us to look at how melatonin is produced in children with autism who have sleep problems.	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. Other Name: Natrol brand liquid melatonin
Placebo Comparator: flavored inert liquid Of the 30 targeted participants, 18 will be randomized at the first three week dosing period {1mg of melatonin}. The randomization will be single blind to the parent in a 5:1 ratio (15 children will receive melatonin, and 3 children will receive a flavored placebo at the first 3-week period only). After the initial 3-week dose cycle of 1 mg, all children randomized to placebo will begin 3 mg of melatonin and will continue in dose increase (6mg, 9 mg)until they meet the criteria of falling asleep within 30 minutes of bedtime 5/7 nights per week. No child will take more than 9 mg.	Drug: 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. Other Name: Inert flavored liquid manufactored by PharmaCare in Mt. Juliet TN. A certificate of analysis is on file for this compounded liquid.

Arms

Assigned Interventions

Experimental: Pharmacokinetic

We hope to target 12 of the 30 children to be enrolled for this study to participate in a pharmacokinetic arm of the study. These 12 children would be receiving overnight sleep studies prior to receiving the first dose of melatonin and again at about every 3 week intervals each time the dose increases until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. During the sleep studies an intravenous catheter will be placed in the child's arm to sample small amounts of blood throughout the day (about 3 teaspoons of blood)to allow us to look at how melatonin is produced in children with autism who have sleep problems.

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.

Other Name: Natrol brand liquid melatonin

Placebo Comparator: flavored inert liquid

Of the 30 targeted participants, 18 will be randomized at the first three week dosing period {1mg of melatonin}. The randomization will be single blind to the parent in a 5:1 ratio (15 children will receive melatonin, and 3 children will receive a flavored placebo at the first 3-week period only). After the initial 3-week dose cycle of 1 mg, all children randomized to placebo will begin 3 mg of melatonin and will continue in dose increase (6mg, 9 mg)until they meet the criteria of falling asleep within 30 minutes of bedtime 5/7 nights per week. No child will take more than 9 mg.

Drug: 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.

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

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.

Eligibility

Ages Eligible for Study:	4 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927030

Locations

United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2551

Sponsors and Collaborators

Vanderbilt University

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

Investigators

Principal Investigator:

Beth A Malow, MD, MS

Vanderbilt University

More Information

No publications provided

Responsible Party:	Beth Ann Malow, Professor, Departments of Neurology and Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00927030 History of Changes
Other Study ID Numbers:	071269
Study First Received:	June 22, 2009
Last Updated:	June 28, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Autism
children
sleep
insomnia

Additional relevant MeSH terms:

Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Autistic Disorder
Sleep Initiation and Maintenance Disorders
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013

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