Blind Elderly Melatonin Treatment Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00692094
First received: May 30, 2008
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention
Blindness
Biological: Melatonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Melatonin Entrainment of Elderly Blind Free-runners

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Circadian phase marker, as measured by the melatonin levels in serial salivary and/or plasma samples. [ Time Frame: biweekly throughout the entire study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2004
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00692094

Locations
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
Investigators
Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
  More Information

Additional Information:
Publications:
Responsible Party: Alfred Lewy, Senior Vice Chair & Professor, Psychiatry, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00692094     History of Changes
Other Study ID Numbers: eIRB 0194, R01 AG21826
Study First Received: May 30, 2008
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
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 22, 2014