Official Title: “Melatonin Studies of Blind Children”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

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).

Intervention(s) in this Clinical Trial

• Dietary Supplement: Melatonin
  • 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).
• Dietary Supplement: Melatonin
  • 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).
• Dietary Supplement: Melatonin
  • 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).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
• Experimental: 2
  • Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
• Experimental: 3
  • Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.

Primary Measures

• circadian phase marker, as measured by the melatonin levels in serial salivary and/or plasma samples.
  • Time Frame: biweekly throughout the entire study
    Safety Issue?: No

Secondary Measures

• Durability and Toxicity Side Effects Questionnaire
  • Time Frame: 1 year
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 20 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Alfred J Lewy, MD, PhD Principal Investigator Oregon Health and Science University  

Overall Contact: Jeannie B Songer, B.A. 503-418-4144 songerj@ohsu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691444

Study ID Number: eIRB 1251

ClinicalTrials.gov Identifier: NCT00691444

Health Authority: United States: Food and Drug Administration

OHSU Sleep and Mood Disorders Laboratory website