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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00114322
First received: June 14, 2005
Last updated: January 12, 2007
Last verified: June 2005
  Purpose

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 Intervention
Seasonal Affective Disorder
Device: light exposure from LED source at narrow 468 nm or broader 400-700 nm wavelength

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparing Wavelengths Using LED Light for SAD Treatment

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

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

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

Estimated Enrollment: 24
Study Start Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114322

Locations
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    jlanderson@partners.org   
Contact: Ian C Shempp    617-525-7641      
Principal Investigator: Janis L Anderson, Ph.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Janis L Anderson, Ph.D Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114322     History of Changes
Other Study ID Numbers: 2005-P-000160
Study First Received: June 14, 2005
Last Updated: January 12, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014