Blind Elderly Melatonin Treatment Study

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Blindness

Treatments: Biological: Melatonin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00692094

R01AG021826 (U.S. NIH Grant/Contract)

eIRB 0194

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 4 patient groups

1

Experimental group

Description:

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.

Treatment:

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

2

Experimental group

Description:

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.

Treatment:

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

3

Experimental group

Description:

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.

Treatment:

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

4

Experimental group

Description:

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.

Treatment:

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin

Biological: Melatonin