Expired Study
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Portland, Oregon 97239


Purpose:

The primary two foci of this five-year study will be to assess inter-individual variability in the timing of the body clock of blind individuals, and to optimize the melatonin dosing regimen for synchronizing body clocks of blind individuals to the 24-hour day.


Study summary:

The first part of the study is observational, in which the body clock rhythms of blind individuals are assessed for variability in patterns across subjects. The second part of the study involves a melatonin treatment (0.025-20 mg). The dose for each subject will be determined by the previous, observational data collected on the specifics of their individual body clock. The purpose of the intervention is to find an optimized dosing regimen and administration time to synchronize the body clocks of blind individuals, that seem to operate independent of the 24-hour environmental light/dark cycle, to the 24-hour day.


Criteria:

Inclusion Criteria: - blindness for at least one year, verified by an ophthalmologic exam - ability to comply with the requirements of the experimental protocol - competency 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 - external demands that limit the ability to maintain a regular schedule (e.g. night shift work) - pregnancy


Study is Available At:


Original ID:

eIRB 1029


NCT ID:

NCT00686907


Secondary ID:

9R01 EY018312-09A1


Study Acronym:


Brief Title:

Blind Adult Melatonin Treatment Study


Official Title:

Melatonin for Circadian Sleep Disorders in the Blind


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Eye Institute (NEI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:March 2007
Completion Date:July 2013
Completion Type:Anticipated
Primary Completion Date:July 2013
Primary Completion Type:Anticipated
Verification Date:October 2012
Last Changed Date:October 23, 2012
First Received Date:May 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Actigraph watch data as a means to see how melatonin treatment affects the subjects sleep/activity patterns.
Time Frame:Longitudinal study, up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Circadian phase marker, as measured by the levels of melatonin in serial salivary and/or plasma samples
Time Frame:Longitudinal study, up to 5 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Melatonin
Description:Dose range: 0.01 mg - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).
Arm Name:A

Study Arms

Study Arm Type:Experimental
Arm Name:A
Description:Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Eye Institute (NEI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. Review. No abstract available.
PMID:10810544
Reference Type:Reference
Citation:Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. Review.
PMID:16687313
Reference Type:Reference
Citation:Emens JS, Lewy AJ, Lefler BJ, Sack RL. Relative coordination to unknown "weak zeitgebers" in free-running blind individuals. J Biol Rhythms. 2005 Apr;20(2):159-67.
PMID:15834112

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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