Blind Child Melatonin Treatment Study

Oregon Health and Science University10 enrolled

Overview

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 some subjects).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Blindness

Interventions

MelatoninDIETARY_SUPPLEMENT

Subjects will be given up to 0.5 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

MelatoninDIETARY_SUPPLEMENT

Subjects will be given up to 10 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

MelatoninBIOLOGICAL

Subjects will be given up to 20 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

Eligibility

Sex: ALLMin age: 5 YearsMax age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sleep and Mood Disorders Lab, Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

Time frame: biweekly throughout the entire study

Secondary Outcomes

Durability and Toxicity Side Effects Questionnaire

Time frame: 1 year

Data from ClinicalTrials.gov

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