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Melatonin Levels in Smith Magenis Syndrome (SMS)

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ClinicalTrials.gov Identifier: NCT00691574
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : June 5, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Information provided by (Responsible Party):
Oregon Health and Science University

Brief Summary:
The goal of this pilot project is to determine whether melatonin levels are disordered in patients with Smith-Magenis Syndrome (SMS) and whether melatonin treatment can correct abnormal circadian rhythms in SMS patients. In addition, the study investigates the effects of bright light in an elderly control population that exhibits low melatonin secretion.

Condition or disease Intervention/treatment Phase
Chromosome Disorders Dietary Supplement: Melatonin Device: Enviro-light artificial light box Not Applicable

Detailed Description:

Participation involves 5 stages for SMS patients. First, Subjects will complete 4 sessions of 25-hour salivary or plasma sampling, with the last sampling occurring in front of a bright light box. Second, subjects will enroll in the melatonin treatment phase, involving a daily dose (up to 3 mg) for up to one year, with frequent (every 2-4 weeks) of 25-hour salivary or plasma sampling. During this stage, the subject and/or caregiver may also be asked to wear an activity wrist monitor, complete a daily sleep diary and behavioral questionnaires. Third, the subject may be asked to complete up to 3 25-hour sampling periods and take a melatonin pill on the same day to test how their body metabolizes the hormone, melatonin. The fourth stage is for subjects who are found to have an abnormal body rhythm. Subjects will complete a 25-hour plasma sampling period under bedrest to test for a hormone, Cortisol. The fifth stage is an optional 12-hour sleep analysis (polysomnography) to test for sleep disorders.

Control participants will complete an abbreviated protocol of the 3 baseline 25-hour sampling periods and 1 involving bright light exposure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Melatonin Levels in Sleep-disordered Smith-Magenis Syndrome: a Pilot Study
Study Start Date : September 1998
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: 2
Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.
Device: Enviro-light artificial light box
Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA.
Other Name: bright light treatment

Experimental: 1
Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.
Dietary Supplement: Melatonin
up to 3 mg, daily, for up to 1 year

Primary Outcome Measures :
  1. Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples [ Time Frame: every 2-4 weeks throughout the entire study ]

Secondary Outcome Measures :
  1. Polysomnography Sleep Disorder Assessment [ Time Frame: 1 optional, 12-hour assessment towards the end of the study ]
  2. Wrist Actigraph Activity Levels as a Secondary Indicator of Circadian Phase [ Time Frame: every 2-4 weeks throughout the entire study along with every Circadian Phase Marker assessment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Control participants:

    • 30 individuals: ages 55-85,
    • healthy without significant active medical problems.
  • SMS patients:

    • 20 individuals: ages 3-50,
    • with a clinical diagnosis of Smith-Magenis Syndrome by a qualified Medical Geneticist, confirmed by cytogenetic analysis documenting deletion of chromosome band 17p11.2.

Exclusion Criteria:

  • Control participants:

    • A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual, abnormal heart, liver or kidney function, diagnoses of neurodegenerative or cerebrovascular disease (Alzheimer's disease, Parkinson's disease, stroke, etc.),
    • cognitive impairment (Mini-Mental State Score < 23) but without a formal diagnosis of dementia,
    • active symptoms of depression (Geriatric Depression Scale: 30 pt. version > 10),
    • current diagnosis of cataracts,
    • macular degeneration or retinopathy based on eye exam by an optometrist or ophthalmologist within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691574

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United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Eilis Boudreau, MD Oregon Health and Science University
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Responsible Party: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00691574    
Other Study ID Numbers: eIRB 0668
n/a unfunded
First Posted: June 5, 2008    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Oregon Health and Science University:
Smith-Magenis Syndrome
circadian rhythm
Additional relevant MeSH terms:
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Smith-Magenis Syndrome
Chromosome Disorders
Chronobiology Disorders
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants