Blind Elderly Melatonin Treatment Study

NCT00692094 | Terminated Results DMC

• 2 other identifiers: eIRB 0194R01AG021826
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Blindness

Keywords

melatonin; circadian rhythms; sleep

Outcome Measures

Primary Outcomes (1)

• Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

  biweekly throughout the entire study

Secondary Outcomes (1)

• Durability and Toxicity Side Effects Questionnaire

  1 year

Study Arms (4)

1

EXPERIMENTAL

Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.

Biological: Melatonin

2

EXPERIMENTAL

Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.

Biological: Melatonin

3

EXPERIMENTAL

Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.

Biological: Melatonin

4

EXPERIMENTAL

Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.

Biological: Melatonin

Interventions

Melatonin BIOLOGICAL

0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.

1

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Sleep and Mood Disorders Lab, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. doi: 10.1007/0-306-46814-x_51. No abstract available.

  PMID: 10810544 BACKGROUND

• 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. doi: 10.1056/NEJM200010123431503.

  PMID: 11027741 BACKGROUND

• 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. doi: 10.1016/s0006-8993(01)02964-x.

  PMID: 11684046 BACKGROUND

• 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. doi: 10.1080/07420520500398064.

  PMID: 16393710 RESULT

MeSH Terms

Conditions

Blindness

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Analyses were not completed because, a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

Results Point of Contact

• Title: OHSU Integrity Department
• Organization: Oregon Health and Science University

irb@ohsu.edu

1-877-733-8313

Study Officials

• Alfred J Lewy, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 6, 2008
• Study Start: August 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)