NCT00692094

Blind Elderly Melatonin Treatment Study

Melatonin Entrainment of Elderly Blind Free-runners

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Blindness

Interventions

Type	Name	Description
BIOLOGICAL	Melatonin	0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
BIOLOGICAL	Melatonin	0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
BIOLOGICAL	Melatonin	0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
BIOLOGICAL	Melatonin	0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.

Timeline

• Start date: 2004-08-01
• Primary completion: 2008-05-01
• Completion: 2008-12-01
• First posted: 2008-06-06
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States