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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Device: light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparing Wavelengths Using LED Light for SAD Treatment
Study Start Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. score on depression rating scale at weeks 1, 2, and 3 by rater blind to treatment condition

Secondary Outcome Measures :
  1. score on hypomania/mania rating scale at weeks 1, 2, and 3
  2. adverse effects reported to rater blind to treatment condition

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 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   
Contact: Ian C Shempp    617-525-7641      
Principal Investigator: Janis L Anderson, Ph.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Janis L Anderson, Ph.D Brigham and Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00114322     History of Changes
Other Study ID Numbers: 2005-P-000160
First Posted: June 15, 2005    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: June 2005

Additional relevant MeSH terms:
Mood Disorders
Seasonal Affective Disorder
Mental Disorders
Depressive Disorder