Blind Adult Melatonin Treatment Study

Blindness Clinical Trial

Official title:

Melatonin for Circadian Sleep Disorders in the Blind

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00686907
• Other study ID #: eIRB 1029
• Secondary ID: 9R01EY018312-09A
• Status: Active, not recruiting
• Phase: N/A
• First received: May 28, 2008
• Last updated: October 23, 2012
• Start date: March 2007
• Est. completion date: July 2013

Study information

• Verified date: October 2012
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary two foci of this five-year study will be to assess inter-individual variability in the timing of the body clock of blind individuals, and to optimize the melatonin dosing regimen for synchronizing body clocks of blind individuals to the 24-hour day.

Description:

The first part of the study is observational, in which the body clock rhythms of blind individuals are assessed for variability in patterns across subjects. The second part of the study involves a melatonin treatment (0.025-20 mg). The dose for each subject will be determined by the previous, observational data collected on the specifics of their individual body clock. The purpose of the intervention is to find an optimized dosing regimen and administration time to synchronize the body clocks of blind individuals, that seem to operate independent of the 24-hour environmental light/dark cycle, to the 24-hour day.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• blindness for at least one year, verified by an ophthalmologic exam

• ability to comply with the requirements of the experimental protocol

• competency to sign informed consent

Exclusion Criteria:

• abnormal heart, liver or kidney function

• a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual

• external demands that limit the ability to maintain a regular schedule (e.g. night shift work)

• pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blindness

Intervention

Drug:
• Melatonin
Dose range: 0.01 mg - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).

Locations

Country	Name	City	State
United States	Sleep and Mood Disorders Lab, Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Emens JS, Lewy AJ, Lefler BJ, Sack RL. Relative coordination to unknown "weak zeitgebers" in free-running blind individuals. J Biol Rhythms. 2005 Apr;20(2):159-67. — View Citation

Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. Review. — View Citation

Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian phase marker, as measured by the levels of melatonin in serial salivary and/or plasma samples		Longitudinal study, up to 5 years	No
Secondary	Actigraph watch data as a means to see how melatonin treatment affects the subjects sleep/activity patterns.		Longitudinal study, up to 5 years	No

External Links

•   OHSU Sleep and Mood Disorders Laboratory website