Light-Emitting Diode (LED) Light for Seasonal Affective Disorder (SAD) Treatment
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|ClinicalTrials.gov Identifier: NCT00114322|
Recruitment Status : Unknown
Verified June 2005 by Brigham and Women's Hospital.
Recruitment status was: Recruiting
First Posted : June 15, 2005
Last Update Posted : January 15, 2007
Recurrent fall/winter major depression (known as Seasonal Affective Disorder (SAD)) is a prevalent and disruptive disorder whose pathophysiological basis is unknown, but several hypotheses attribute a causal role to the circadian timing system. Bright white light exposure via the retina has been shown to reverse the symptoms of SAD. Recent physiological studies demonstrated the existence of retinal ganglion cells capable of transducing light input to the retinohypothalamic tract, the primary circadian afferent in humans. This retinohypothalamic system appears to be maximally sensitive to light in the 446-477nm (violet/blue) range.
Using light-emitting diode (LED) technology, light of narrow bandwidths now can be delivered from a safe, relatively inexpensive device. We propose to contrast in SAD patients the efficacy and tolerability of 468 nm LED light from a portable 11cm x 6cm commercially-available device (GoLITEÔ) to a broader 400-700 nm wavelength LED-generated light housed in an identical device. The broad wavelength (white) light from our LED device is similar to that from cool-white fluorescent 10,000 lux devices currently the standard for treatment of SAD (see e.g., Lam & Levitt, 1999).
Twenty-four depressed SAD outpatients will be randomized to a 3-week trial of light therapy using either the narrow 468 nm LED source or the broader 400-700 nm LED source, each housed in a GoLITEÔ device. Subjects will be given devices and written instruction for administering daily treatments at home, 45min every (q) a.m. The devices will be described to subjects in terms of wavelength but not specifically described as "blue" or "white." Weekly depression ratings and assessments of adverse effects will be obtained by a trained rater blind to the treatment condition. Depressive symptoms will be rated weekly by the same trained clinician.
The following hypotheses will be evaluated:
- H1-- Depressed SAD patients will demonstrate greater antidepressant therapeutic benefit from the narrow-wavelength (blue) source than from the broad-wavelength (white) source.
- H2-- Depressed SAD patients will manifest fewer adverse effects during treatment with the narrow-wavelength (blue) source than with the broad-wavelength (white) source.
|Condition or disease||Intervention/treatment|
|Seasonal Affective Disorder||Device: light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparing Wavelengths Using LED Light for SAD Treatment|
|Study Start Date :||May 2005|
- score on depression rating scale at weeks 1, 2, and 3 by rater blind to treatment condition
- score on hypomania/mania rating scale at weeks 1, 2, and 3
- adverse effects reported to rater blind to treatment condition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114322
|United States, Massachusetts|
|SAD Clinical Services, BWH Psychiatry; 221 Longwood Ave.||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Janis L Anderson, Ph.D. 617-732-7993 email@example.com|
|Contact: Ian C Shempp 617-525-7641|
|Principal Investigator: Janis L Anderson, Ph.D.|
|Principal Investigator:||Janis L Anderson, Ph.D||Brigham and Women's Hospital|