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Blind Adult Melatonin Treatment Study

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ClinicalTrials.gov Identifier: NCT00686907
Recruitment Status : Unknown
Verified October 2012 by Alfred Lewy, National Eye Institute (NEI).
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2008
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Blindness Drug: Melatonin

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Melatonin for Circadian Sleep Disorders in the Blind
Study Start Date : March 2007
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686907


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

Additional Information:
Publications:
Responsible Party: Alfred Lewy, MD, PhD / Senior Vice Chairman, Department of Psychiatry, Oregon Health & Science University, National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00686907     History of Changes
Other Study ID Numbers: eIRB 1029
9R01EY018312-09A1 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants