TerminatedNot Applicable

Melatonin Levels in Smith Magenis Syndrome (SMS)

Stopped: Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.

United States5 participantsStarted 1998-09

Plain-language 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.

Who can participate

Age range3 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples

Timeframe: every 2-4 weeks throughout the entire study

Trial details

NCT IDNCT00691574

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2019-11-08