Blind Child Melatonin Treatment Study

Stopped early · Not applicable

Conditions studied: Blindness

In brief

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.

Key facts

Study ID

NCT00691444

Run by

Oregon Health and Science University

People needed

10

Starts

2002-09-01

Expected to finish

2015-12-01

Last updated by the study team

2019-11-27

Who can join

Age: 5 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sleep and Mood Disorders Lab, Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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