Status:
TERMINATED
Melatonin Levels in Smith Magenis Syndrome (SMS)
Lead Sponsor:
Oregon Health and Science University
Conditions:
Chromosome Disorders
Eligibility:
All Genders
3-85 years
Phase:
NA
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 rhyt...
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. Seco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00691574
Start Date
September 1 1998
End Date
May 1 2009
Last Update
November 27 2019
Active Locations (1)
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1
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239