The primary focus of this five-year study will be to optimize the melatonin dosing regimen
for synchronizing the body clocks of blind children to the 24-hour day.
We intend to study as many as 26 blind children through up to three 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 3 treatment plans differ only in the start
dose. Successfully treated subjects (of one treatment plan) 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
- Children and adults 5 to 20 years old
- Blindness for at least one year, verified by an ophthalmologic exam
- Ability to comply with the requirements of the experimental protocol
- And no clinically significant abnormalities (other than blindness) on a general
- Subjects must be competent to sign informed consent if age 18 or older. Parents and
subjects will be interviewed together and, when appropriate (for example, subject is
age 18 or older), separately as well.
- Abnormal heart, liver or kidney function; intractable seizure disorders
- Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip
- Pregnancy; sexual activity in post-pubertal females not using a recognized and valid
- A current Axis I psychiatric or substance abuse disorder according to the DSM-IV
Manual ; OR
- External demands that limit the ability to maintain a regular schedule, e.g. night