Blind Adult Melatonin Treatment Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alfred Lewy, National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00686907
First received: May 28, 2008
Last updated: October 23, 2012
Last verified: October 2012
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
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, 9R01 EY018312-09A1
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:
Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014