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Portland, Oregon 97239


Purpose:

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.


Study summary:

The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).


Criteria:

Inclusion Criteria: - Adults 55-100 years old - Blindness for at least one year, verified by an ophthalmologic exam - Ability to comply with the requirements of the experimental protocol - No clinically significant abnormalities (other than blindness) on a general physical examination - Subjects must be competent to sign informed consent Exclusion Criteria: - Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual - A diagnosis of obstructive sleep apnea (apnea index > 10) or nocturnal myoclonus (> 10 associated arousals/hour) - External demands that limit the ability to maintain a regular schedule, e.g., night shift work


NCT ID:

NCT00692094


Primary Contact:

Principal Investigator
Alfred J Lewy, MD, PhD
Oregon Health and Science University


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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