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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00269633
Other study ID # 080-19000-J11401
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received December 22, 2005
Last updated May 12, 2015
Start date November 2006
Est. completion date November 2015

Study information

Verified date May 2015
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date November 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Light Box


Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Thomas Jefferson University Apollo Health Systems

Country where clinical trial is conducted

United States, 

References & Publications (8)

Brainard GC, Sherry D, Skwerer RG, Waxler M, Kelly K, Rosenthal NE. Effects of different wavelengths in seasonal affective disorder. J Affect Disord. 1990 Dec;20(4):209-16. — View Citation

Eastman CI, Young MA, Fogg LF, Liu L, Meaden PM. Bright light treatment of winter depression: a placebo-controlled trial. Arch Gen Psychiatry. 1998 Oct;55(10):883-9. — View Citation

Glickman G, Byrne B, Pineda C, Hauck WW, Brainard GC. Light therapy for seasonal affective disorder with blue narrow-band light-emitting diodes (LEDs). Biol Psychiatry. 2006 Mar 15;59(6):502-7. Epub 2005 Sep 13. — View Citation

Lee TM, Chan CC, Paterson JG, Janzen HL, Blashko CA. Spectral properties of phototherapy for seasonal affective disorder: a meta-analysis. Acta Psychiatr Scand. 1997 Aug;96(2):117-21. — View Citation

Lewy AJ, Bauer VK, Cutler NL, Sack RL, Ahmed S, Thomas KH, Blood ML, Jackson JM. Morning vs evening light treatment of patients with winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):890-6. — View Citation

Lewy AJ, Kern HA, Rosenthal NE, Wehr TA. Bright artificial light treatment of a manic-depressive patient with a seasonal mood cycle. Am J Psychiatry. 1982 Nov;139(11):1496-8. — View Citation

Oren DA, Brainard GC, Johnston SH, Joseph-Vanderpool JR, Sorek E, Rosenthal NE. Treatment of seasonal affective disorder with green light and red light. Am J Psychiatry. 1991 Apr;148(4):509-11. — View Citation

Rosenthal NE, Sack DA, Gillin JC, Lewy AJ, Goodwin FK, Davenport Y, Mueller PS, Newsome DA, Wehr TA. Seasonal affective disorder. A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry. 1984 Jan;41(1):72-80. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); weekly for three weeks
Secondary Quality of Life in Depression Scale (QLDS); before and after 3-week study
See also
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