Clinical Trial: Blind Elderly Melatonin Treatment Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Melatonin Entrainment of Elderly Blind Free-runners

Brief Summary: 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.

Detailed 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).
Sponsor: Oregon Health and Science University

Current Primary Outcome: Circadian phase marker, as measured by the melatonin levels in serial salivary and/or plasma samples. [ Time Frame: biweekly throughout the entire study ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: May 30, 2008
Date Started: August 2004
Date Completion:
Last Updated: April 8, 2014
Last Verified: April 2014