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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Apollo Health Systems
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00269633
First received: December 22, 2005
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The specific aim of this study is to test the hypothesis that light stimuli concentrated around 468 nm will evoke a significantly stronger therapeutic response in SAD patients compared to light stimuli concentrated around 654 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.


Condition Intervention Phase
Seasonal Affective Disorder
Device: Light Box
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Optimizing Light Wavelength for Treatment of Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); weekly for three weeks

Secondary Outcome Measures:
  • Quality of Life in Depression Scale (QLDS); before and after 3-week study

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00269633

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Apollo Health Systems
Investigators
Principal Investigator: George C Brainard, Ph.D. Thomas Jefferson University
  More Information

Publications:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00269633     History of Changes
Other Study ID Numbers: 080-19000-J11401
Study First Received: December 22, 2005
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Seasonal Affective Disorder

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

ClinicalTrials.gov processed this record on July 23, 2014