Research Study of Treatment for Winter Depression With Different Colors of Light

This study has been completed.
Sponsor:
Collaborator:
Apollo Health Systems
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00269633
First received: December 22, 2005
Last updated: March 2, 2016
Last verified: March 2016

December 22, 2005
March 2, 2016
November 2006
May 2008   (final data collection date for primary outcome measure)
Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks [ Time Frame: Averaged over Three Weeks During Treatment ] [ Designated as safety issue: No ]
Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.
Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks
Complete list of historical versions of study NCT00269633 on ClinicalTrials.gov Archive Site
Not Provided
Quality of Life in Depression Scale (QLDS); before and after 3-week study
Not Provided
Not Provided
 
Research Study of Treatment for Winter Depression With Different Colors of Light
Optimizing Light Wavelength for Treatment of Seasonal Affective Disorder

The specific aim of this study is to test the hypothesis that light stimuli concentrated around 467 nm will evoke a significantly stronger therapeutic response in SAD patients compared to light stimuli concentrated around 657 nm at an equal photon density.

The secondary objective of this study is to determine the efficacy of different colors and levels of light in order to optimize therapeutic benefit, while also minimizing side effects and maintaining safety of light exposure.

Studies report as many as 1 out of every 5 Americans is affected by mild to severe Seasonal Affective Disorder (SAD, winter depression). Although the exact cause of this condition is unknown, bright light has proven to be an effective therapeutic treatment for many people with SAD. The light sources that have been traditionally used for treatment of SAD produce white light with great variability in the balance of wavelengths that are emitted across the visible spectrum. Although several studies have attempted to test the effectiveness of different wavelengths for treatment of SAD, the devices used in those studies employed broad bandwidths of light. With the technological advancements in light emitting diodes (LEDs) the production of new light therapy equipment with much narrower bandwidths of light is possible. Side effects of exposure to traditional white light therapy for SAD have included hypomanic activation, irritability, headache, eyestrain and nausea. We hypothesize that when the wavelength of light therapy is optimized, it should be feasible to elicit strong therapeutic benefits with lower light intensities and fewer side effects. Previous studies, approved by the Jefferson IRB and successfully completed by our laboratory have shown that some colors of light are more effective in treating SAD than other colors.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Seasonal Affective Disorder
  • Device: Blue Light Box 467 nm
    467 nm Blue LED Light
  • Device: Red Light Box 657 nm
    657 nm Red LED Light
  • Placebo Comparator: Red Light Box 657 nm
    Red Light Box 657 nm
    Intervention: Device: Red Light Box 657 nm
  • Active Comparator: Blue Light Box 467 nm
    Blue Light Box 467 nm
    Intervention: Device: Blue Light Box 467 nm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Seasonal Affective Disorder
  • Over 18 years old
  • Stable sleeping pattern with a bedtime no later than 1 a.m.

Exclusion Criteria:

  • Pregnant women
  • Concurrent psychiatric illness that would preclude compliance with the protocol
  • active suicidal or homicidal ideation or plan
  • variable psychiatric illness (i.e. rapid cycling disorder or severe premenstrual syndrome)
  • individuals with substance abuse or dependence who have not been in remission for at least one year
  • individuals taking photosensitizing medications
  • individuals with macular degeneration or other ocular conditions which might be adversely affected by light
  • less then six weeks after onset of psychotherapeutic treatment
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269633
080-19000-J11401
Yes
No
Not Provided
Thomas Jefferson University
Thomas Jefferson University
Apollo Health Systems
Principal Investigator: George C Brainard, Ph.D. Thomas Jefferson University
Thomas Jefferson University
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP