Autistic DisorderPhase 1NICHDNCT00927030
Melatonin for Sleep in Children With Autism
A Phase 1 study testing supplemental liquid melatonin and flavored liquid or liquid supplemental melatonin in people with Autistic Disorder and Insomnia, run by Vanderbilt University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autistic Disorder, Insomnia
- What is being tested?
- supplemental liquid melatonin and flavored liquid or liquid supplemental melatonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Medical Center
Nashville, Tennessee, 37232-2551
About this study
Official title: Melatonin for Sleep in Children With Autism: Safety Tolerability and Dose
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).
Read the 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.
- Conditions
- Autistic Disorder, Insomnia
- Being tested
- supplemental liquid melatonin, flavored liquid or liquid supplemental melatonin
- Keywords
- Autism, children, sleep, insomnia
- Medical subject headings
- Autistic Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplemental liquid melatoninDrug
Also called Natrol brand 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 melatoninDrug
Also called Inert flavored liquid manufactored by PharmaCare in Mt. Juliet TN. A certificate of analysis is on file for this compounded liquid.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Experimental | 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. Receives: Drug: supplemental liquid melatonin |
| flavored inert liquid | Placebo comparator | 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. Receives: Drug: flavored liquid or liquid supplemental melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism.
Measured: Two Years from study start
Secondary outcomes (2)
A sub-set of 12 children will be studied to characterize the pharmacokinetic profile of orally administered melatonin.
Measured: 2 years from start of study
A group of behavioral and parental stress measures will be piloted for the participants in this study.
Measured: 2 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Beth Ann Malow, Vanderbilt University
- Investigators
- Beth A Malow, MD, MS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927030
- Sponsor's protocol ID
- 071269
- Acronym
- NICHD
- Status last verified
- Jun 2012
- First submitted
- 22 Jun 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin for Sleep in Children With Autism: Safety Tolerability and Dose
- ClinicalTrials.gov ID
- NCT00927030
- Acronym / sponsor ID
- NICHD / 071269
- Conditions
- Autistic Disorder, Insomnia
- Keywords
- Autism, children, sleep, insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Experimental | Drug: supplemental liquid melatoninWe 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. |
| flavored inert liquid | Placebo comparator | Drug: flavored liquid or liquid supplemental melatoninOf 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplemental liquid melatoninAlso: Natrol brand liquid melatoninLiquid 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. | Drug | Pharmacokinetic |
| flavored liquid or liquid supplemental melatoninAlso: Inert flavored liquid manufactored by PharmaCare in Mt. Juliet TN. A certificate of analysis is on file for this compounded liquid.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. | Drug | flavored inert liquid |
Primary outcome
Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism.
Time frame: Two Years from study start
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Malow, MD, MS principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing supplemental liquid melatonin and flavored liquid or liquid supplemental melatonin in people with Autistic Disorder and Insomnia, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine dose-response, tolerability, and adverse effects of melatonin in 30 children with autism. (time frame: Two Years from study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.