Blind Adult Melatonin Treatment Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Alfred Lewy, National Eye Institute (NEI) Identifier:
First received: May 28, 2008
Last updated: October 23, 2012
Last verified: October 2012
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
Drug: Melatonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Melatonin for Circadian Sleep Disorders in the Blind

Resource links provided by NLM:

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: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.
Drug: Melatonin
Dose range: 0.01 mg - 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 (0.025-20 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.

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

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
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Please refer to this study by its identifier: NCT00686907

United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
National Eye Institute (NEI)
Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
  More Information

Additional Information:
Responsible Party: Alfred Lewy, MD, PhD / Senior Vice Chairman, Department of Psychiatry, Oregon Health & Science University, National Eye Institute (NEI) Identifier: NCT00686907     History of Changes
Other Study ID Numbers: eIRB 1029  9R01EY018312-09A1 
Study First Received: May 28, 2008
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):
melatonin, circadian rhythms, sleep

Additional relevant MeSH terms:
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016