Trial Information

Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort

All participants undergo a general neurocognitive evaluation at baseline and 6-month
follow-up, focused on assessment of intelligence, academic skills, attention, processing
speed, memory and executive functions.

Sleep parameters using self-report and actigraphy will be assessed at three time points
during the study: Baseline, 3-months, and 6-months.

Participants will be divided into 3 mutually exclusive groups:

- Cohort 1: Participant has neurocognitive impairment defined as performance on at least
one measure of attention, memory, and/or executive functioning at or below the 10th
percentile, AND is absent of delayed sleep onset latency defined as an inability to
fall asleep within 30 minutes less than once a week during the past month.

- Cohort 2: Participant has neurocognitive impairment defined as performance on at least
one measure of attention, memory, and/or executive functioning at or below the 10th
percentile, AND has delayed sleep onset latency defined as self-report of an inability
to fall asleep within 30 minutes at least once a week during the past month.

- Cohort 3: Participant is absent of neurocognitive impairment defined as performance
>10th percentile on all six measures of attention, memory, and executive functioning,
AND has delayed sleep onset latency defined as self-report of an inability to fall
asleep within 30 minutes > once a week during the past month.

Within each group, participants will be randomly assigned to take either 3 mgs of time
release melatonin or placebo 1-2 hours before bedtime each night for 6 months.

Psychosocial measures of health-related quality of life and psychological distress will be
completed at baseline and following 6 months of melatonin/placebo treatment.

Biological samples for serum melatonin levels will be collected at baseline and at the 6
month follow-up evaluation.