Status:
TERMINATED
Blind Child Melatonin Treatment Study
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Blindness
Eligibility:
All Genders
5-20 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00691444
Start Date
September 1 2002
End Date
December 1 2015
Last Update
November 27 2019
Active Locations (1)
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1
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239