Blind Adult Melatonin Treatment Study - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00686907

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.

Condition	Intervention
Blindness	Dietary Supplement: Melatonin

Drug Information available for: Melatonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Melatonin for Circadian Sleep Disorders in the Blind

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.	Dietary Supplement: Melatonin Dose range: 0.025 - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).

Detailed Description:

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-.5 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686907

Contacts

Contact: Jeannie Songer, B.A.

503-418-4144

songerj@ohsu.edu

Locations

United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Jeannie Songer, B.A. 503-418-4144 songerj@ohsu.edu
Contact: Alfred J Lewy, MD, PhD 503-494-7746 lewy@ohsu.edu
Sub-Investigator: Jonathan S Emens, MD
Principal Investigator: Alfred J Lewy, MD, PhD

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Principal Investigator:

Alfred J Lewy, MD, PhD

Oregon Health and Science University

More Information

OHSU Sleep and Mood Disorders Laboratory website This link exits the ClinicalTrials.gov site

Publications:

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.

Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. Review.

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.

Responsible Party:	Oregon Health & Science University ( Alfred J. Lewy, MD, PhD / Senior Vice Chairman, Department of Psychiatry )
Study ID Numbers:	eIRB 1029, 9R01 EY018312-09A1
Study First Received:	May 28, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686907
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):

melatonin, circadian rhythms, sleep

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Vision Disorders
Eye Diseases

Neurologic Manifestations
Sleep Disorders
Melatonin
Blindness

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009