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

NCT ID: NCT00269633

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-05-31

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.

Conditions

Seasonal Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Red Light Box 657 nm

Red Light Box 657 nm

Group Type: PLACEBO_COMPARATOR

Red Light Box 657 nm

Intervention Type: DEVICE

657 nm Red LED Light

Blue Light Box 467 nm

Blue Light Box 467 nm

Group Type: ACTIVE_COMPARATOR

Blue Light Box 467 nm

Intervention Type: DEVICE

467 nm Blue LED Light

Interventions

Blue Light Box 467 nm

467 nm Blue LED Light

Intervention Type: DEVICE

Red Light Box 657 nm

657 nm Red LED Light

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apollo Health Systems

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George C Brainard, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 16165105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2149726 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9783558 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9272195 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7137404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9783559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2006698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6581756 (View on PubMed)

Other Identifiers

080-19000-J11401

Identifier Type: -

Identifier Source: org_study_id