Light-Emitting Diode (LED) Light for Seasonal Affective Disorder (SAD) Treatment

NCT00114322 | Unknown

• 1 other identifier: 2005-P-000160
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seasonal Affective Disorder

Outcome Measures

Primary Outcomes (1)

• score on depression rating scale at weeks 1, 2, and 3 by rater blind to treatment condition

Secondary Outcomes (2)

• score on hypomania/mania rating scale at weeks 1, 2, and 3

• adverse effects reported to rater blind to treatment condition

Interventions

light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength DEVICE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and graphic diagnostic tool
• Free of medical illness, not pregnant, as determined by detailed history and physical examination including blood and urine chemistries and thyroid function tests

You may not qualify if:

• History of concurrent psychiatric illness that would preclude compliance with the protocol and ability to complete the study safely
• Active suicidal or homicidal ideation or plan
• Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect
• History of substance abuse/dependence with less than one year remission
• GAF \< 50
• Light treatment in the previous month
• Pregnant or lactating
• Antidepressant medications in the previous month
• Nightwork or other habitual alteration of sleep/wake cycle
• Medical conditions that affect mood or produce hallmark symptoms of mood disorder
• Use of photosensitizing medications (amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin) or remedies (St. John's wort)
• Macular degeneration or cataract

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

SAD Clinical Services, BWH Psychiatry; 221 Longwood Ave.

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Anderson JL, Glod CA, Dai J, Cao Y, Lockley SW. Lux vs. wavelength in light treatment of Seasonal Affective Disorder. Acta Psychiatr Scand. 2009 Sep;120(3):203-12. doi: 10.1111/j.1600-0447.2009.01345.x. Epub 2009 Feb 3.

  PMID: 19207131 DERIVED

Related Links

• study announcement

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janis L Anderson, Ph.D

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2005
• First Posted: June 15, 2005
• Study Start: May 1, 2005
• Last Updated: January 15, 2007

Record last verified: 2005-06

Locations

US (1)