Official Title: “Melatonin for Circadian Sleep Disorders in the Blind”

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 Type: Interventional

Study Design: Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: February 2012

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.

Intervention(s) in this Clinical Trial

• 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).

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Eye Institute (NEI)

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Jeannie Songer, B.A. 503-418-4144 songerj@ohsu.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00686907

Study ID Number: eIRB 1029

ClinicalTrials.gov Identifier: NCT00686907

Health Authority: United States: Food and Drug Administration

OHSU Sleep and Mood Disorders Laboratory website