Clinical trial NCT00691444: Blind Child Melatonin Treatment Study
Official title: Melatonin Studies of Blind Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blindness
Keywords: melatonin
circadian rhythms
sleep
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 some subjects).

Eligibility criteria: Inclusion Criteria:

* 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 physical examination.
* 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.

Exclusion Criteria:

* Abnormal heart, liver or kidney function; intractable seizure disorders
* Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip stick method)
* Pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method
* 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 shift work.

Primary outcomes:
measure: Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
timeFrame: biweekly throughout the entire study
Secondary outcomes:
measure: Durability and Toxicity Side Effects Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Sleep and Mood Disorders Lab, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alfred J Lewy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. doi: 10.1080/07420520500545862.
citation: Stores G, Ramchandani P. Sleep disorders in visually impaired children. Dev Med Child Neurol. 1999 May;41(5):348-52. doi: 10.1017/s0012162299000766. No abstract available.