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

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Blue Light Box 467 nm
Red Light Box 657 nm
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring Seasonal Affective Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Red Light Box 657 nm

Blue Light Box 467 nm

Arm Description

Red Light Box 657 nm

Blue Light Box 467 nm

Outcomes

Primary Outcome Measures

Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks
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.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2005
Last Updated
March 2, 2016
Sponsor
Thomas Jefferson University
Collaborators
Apollo Health Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00269633
Brief Title
Research Study of Treatment for Winter Depression With Different Colors of Light
Official Title
Optimizing Light Wavelength for Treatment of Seasonal Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Apollo Health Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
Seasonal Affective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red Light Box 657 nm
Arm Type
Placebo Comparator
Arm Description
Red Light Box 657 nm
Arm Title
Blue Light Box 467 nm
Arm Type
Active Comparator
Arm Description
Blue Light Box 467 nm
Intervention Type
Device
Intervention Name(s)
Blue Light Box 467 nm
Intervention Description
467 nm Blue LED Light
Intervention Type
Device
Intervention Name(s)
Red Light Box 657 nm
Intervention Description
657 nm Red LED Light
Primary Outcome Measure Information:
Title
Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks
Description
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.
Time Frame
Averaged over Three Weeks During Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George C Brainard, Ph.D.
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16165105
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. doi: 10.1016/j.biopsych.2005.07.006. Epub 2005 Sep 13.
Results Reference
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PubMed Identifier
2149726
Citation
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. doi: 10.1016/0165-0327(90)90052-a.
Results Reference
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PubMed Identifier
9783558
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. doi: 10.1001/archpsyc.55.10.883.
Results Reference
background
PubMed Identifier
9272195
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. doi: 10.1111/j.1600-0447.1997.tb09915.x.
Results Reference
background
PubMed Identifier
7137404
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. doi: 10.1176/ajp.139.11.1496. No abstract available.
Results Reference
background
PubMed Identifier
9783559
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. doi: 10.1001/archpsyc.55.10.890.
Results Reference
background
PubMed Identifier
2006698
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. doi: 10.1176/ajp.148.4.509.
Results Reference
background
PubMed Identifier
6581756
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. doi: 10.1001/archpsyc.1984.01790120076010.
Results Reference
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Research Study of Treatment for Winter Depression With Different Colors of Light

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