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Blind Elderly Melatonin Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692094
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : June 6, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Oregon Health and Science University

Brief Summary:
The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.

Condition or disease Intervention/treatment Phase
Blindness Biological: Melatonin Not Applicable

Detailed Description:
The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Melatonin Entrainment of Elderly Blind Free-runners
Study Start Date : August 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: 1
Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Biological: Melatonin
0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.

Experimental: 2
Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Biological: Melatonin
0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.

Experimental: 3
Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Biological: Melatonin
0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.

Experimental: 4
Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Biological: Melatonin
0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.




Primary Outcome Measures :
  1. Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. [ Time Frame: biweekly throughout the entire study ]

Secondary Outcome Measures :
  1. Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 55-100 years old
  • Blindness for at least one year, verified by an ophthalmologic exam
  • Ability to comply with the requirements of the experimental protocol
  • No clinically significant abnormalities (other than blindness) on a general physical examination
  • Subjects must be competent 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
  • A diagnosis of obstructive sleep apnea (apnea index > 10) or nocturnal myoclonus (> 10 associated arousals/hour)
  • External demands that limit the ability to maintain a regular schedule, e.g., night shift work

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): NCT00692094


Locations
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United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
Publications of Results:
Other Publications:
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Responsible Party: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00692094    
Other Study ID Numbers: eIRB 0194
R01AG021826 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2008    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Oregon Health and Science University:
melatonin
circadian rhythms
sleep
Additional relevant MeSH terms:
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Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants