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
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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:
MedlinePlus related topics:
Sleep Disorders
Drug Information available for:
Melatonin
U.S. FDA Resources
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
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 June 18, 2013