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

NCT00269633 | Completed Phase 2 Results DMC

• 1 other identifier: 080-19000-J11401
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Affective Disorder

Keywords

Seasonal Affective Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Averaged over Three Weeks During Treatment

Study Arms (2)

Red Light Box 657 nm

PLACEBO COMPARATOR

Red Light Box 657 nm

Device: Red Light Box 657 nm

Blue Light Box 467 nm

ACTIVE COMPARATOR

Blue Light Box 467 nm

Device: Blue Light Box 467 nm

Interventions

Blue Light Box 467 nm DEVICE

467 nm Blue LED Light

Blue Light Box 467 nm

Red Light Box 657 nm DEVICE

657 nm Red LED Light

Red Light Box 657 nm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Apollo Health Systems: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (8)

• 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.

  PMID: 16165105 BACKGROUND

• 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.

  PMID: 2149726 BACKGROUND

• 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.

  PMID: 9783558 BACKGROUND

• 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.

  PMID: 9272195 BACKGROUND

• 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.

  PMID: 7137404 BACKGROUND

• 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.

  PMID: 9783559 BACKGROUND

• 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.

  PMID: 2006698 BACKGROUND

• 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.

  PMID: 6581756 BACKGROUND

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Roseann Talarico
• Organization: Thomas Jefferson University

roseann.talarico@jefferson.edu

215 503 4743

Study Officials

• George C Brainard, Ph.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 23, 2005
• Study Start: November 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)