Blind Elderly Melatonin Treatment Study

Blindness Clinical Trial

Official title:

Melatonin Entrainment of Elderly Blind Free-runners

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00692094
• Other study ID #: eIRB 0194
• Secondary ID: R01AG021826
• Status: Terminated
• Phase: N/A
• Start date: August 2004
• Est. completion date: December 2008

Study information

• Verified date: November 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blindness

Intervention

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.
• Melatonin
0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
• Melatonin
0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
• Melatonin
0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.

Locations

Country	Name	City	State
United States	Sleep and Mood Disorders Lab, Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Lewy AJ, Bauer VK, Hasler BP, Kendall AR, Pires ML, Sack RL. Capturing the circadian rhythms of free-running blind people with 0.5 mg melatonin. Brain Res. 2001 Nov 9;918(1-2):96-100. — View Citation

Lewy AJ, Emens JS, Lefler BJ, Yuhas K, Jackman AR. Melatonin entrains free-running blind people according to a physiological dose-response curve. Chronobiol Int. 2005;22(6):1093-106. — View Citation

Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. Review. — View Citation

Sack RL, Brandes RW, Kendall AR, Lewy AJ. Entrainment of free-running circadian rhythms by melatonin in blind people. N Engl J Med. 2000 Oct 12;343(15):1070-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.		biweekly throughout the entire study
Secondary	Durability and Toxicity Side Effects Questionnaire		1 year