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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| goLITE | Experimental | light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks |
|
| Control | Active Comparator | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goLITE | Device | goLITE at 30 minutes per day, within 30 minutes of waking in the morning |
|
| 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 |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Janis Anderson, PhD | Brigham and Women's Hospital | Principal Investigator |
| Robert Auger, MD | Mayo Clinic | Principal Investigator |
| Scott Crow, MD | University of Minnesota | Principal Investigator |
| Carol Glod, PhD | Mclean Hospital | Principal Investigator |
| Alfredo Rivera, MD | Community Research Management Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States | ||
| Brigham & Women's Hospital |
Subjects in this multicenter trial were recruited and treated at one of five participating sites between January and March 2012. Fifty-six subjects were recruited from 5 health care centers. Twenty-one failed to meet all the inclusion/exclusion criteria, including depression severity and were not randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | goLITE | light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning |
| FG001 | Control | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | goLITE | light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 35 participants that were randomized 29 completed the study the SIGH-ADS at week 6. 3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | goLITE | light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Development Scientisit | Philips | +41 79 460 0622 | fatima.sertkuniyoshi@philips.com |
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| ID | Term |
|---|---|
| D016574 | Seasonal Affective Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Control | Device | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks |
|
| 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 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Community Research Management Associates | Cincinnati | Ohio | 45227 | United States |
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks goLITE: goLITE at 30 minutes per day, within 30 minutes of waking in the morning |
| OG001 | Control | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks |
|
|
|
| Secondary | 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. | Of the 35 participants that were randomized 29 completed the study the SIGH-ADS at week 6. 3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons. Not all participants were able to complete the study related site visits or phone calls. | Posted | Mean | Standard Deviation | units on a scale | weekly, from Week 1 through week 5 |
|
|
|
| Secondary | 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. | Of the 35 participants that were randomized 28 completed the Q-LES-Q-SF at week 6. 3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons. Not all participants were able to complete the study related site visits or phone calls. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 18 |
| 12 |
| 18 |
| EG001 | Control | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks Control: light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks | 0 | 17 | 9 | 17 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus Drainage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus Headache | Nervous system disorders | Non-systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Eye Sensitivity | Eye disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| nasal sinus irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cold | Immune system disorders | Non-systematic Assessment |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| backache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sinus infection | Infections and infestations | Non-systematic Assessment |
|
| hot spot on eye | Eye disorders | Non-systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| eye strain | Eye disorders | Non-systematic Assessment |
|
| facial warming | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| GI upset | Gastrointestinal disorders | Non-systematic Assessment |
|
| itchy/watery eyes | Eye disorders | Non-systematic Assessment |
|
| perimenstrual symptoms | Reproductive system and breast disorders | Non-systematic Assessment | perimenstrual headache and cramps |
|
| white flashing lights | Eye disorders | Non-systematic Assessment |
|
| bloody nose | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| body aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| lightheadedness | Nervous system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Week 2 |
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| Week 3 |
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| Week 4 (phone call) |
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| Week 5 (phone call) |
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| Week 3 |
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| Week 6 |
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