30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.

Detailed Description
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Participants will be randomly assigned to receive either a 467nm light or a 580nm light. Participants will use the light every day for six weeks for 30 minutes. Multiple assessments and questionnaires will be given weekly to assess the efficacy of the treatment.

Official Title
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30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder

Conditions
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Seasonal Affective Disorder

Intervention / Treatment
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* Device: goLITE
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, ages 21-64 Able and willing to provide written informed consent History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Associated, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 2007) *Bipolar I excluded for this study SIGH-ADS score of ≥20 Use of the light device as instructed by the study clinician for at least 6 out of 7 days for the first two weeks of therapy and at least 5 out of 7 days for the remaining four weeks of therapy. Exclusion Criteria: Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator. Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely History or current diagnosis of Bipolar I Disorder Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism) History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria Positive urine drug screen at the Physical Screening Active suicidal or homicidal ideation or plan, as determined by the investigator Global Assessment of Functioning (GAF) <51 (see Appendix B) Use of light therapy treatment within the previous 6 months or any history of goLITE use Pregnant or lactating (will confirm absence of pregnancy with a urine or serum pregnancy test in females of childbearing potential during the Physical Screening. Additional pregnancy tests may be performed as per individual site requirements). Females of child-bearing potential must agree to use some form of birth control throughout the course Current use or use within 2 months of antidepressants or mood stabilizing medications, even if taken for a non-psychiatric indication Currently working night shift or rotating shift or other habitual alteration of the sleep/wake cycle Planned travel outside of the state in which the trial is being conducted Current use or use within the previous 1 month of photosensitizing medications (amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin) or remedies (St. John's wort, melatonin) History of eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye Ishihara score of <10 on the Ishihara Test for Color Deficiency Use of medications, such as tetracycline or oral isoretinoin (Accutane), that would affect the safety of light exposure treatment or that causes complaints of eyestrain or abnormal tearing with computer use of up to 30 minutes at a time

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: goLITE<br>light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks | Device: goLITE<br>* goLITE at 30 minutes per day, within 30 minutes of waking in the morning<br>* Other names: Blue Light;|
| Active Comparator: Control<br>light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks | Device: Control<br>* light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH-ADS Score | A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH-ADS Score (Week 1 Thru 5) | A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized weekly at in person visits or over the phone. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome and the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater. | weekly, from Week 1 through week 5 | 
| Q-LES-Q-SF | The Q-LES-Q-SF (Quality of life enjoyment and satisfaction questionnaire short form) is a 16 question questionnaire that is enables investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Responses to questions range from 1 to 5, 1 being very poor and 5 being very good. Scores range from 16 to 80, the higher score the higher the participants enjoyment and satisfaction. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAD, Seasonal Affective Disorder, Winter Blues, Seasonal Depression