Seasonal Affective Disorder
Conditions
Keywords
SAD, Seasonal Affective Disorder, Winter Blues, Seasonal Depression
Brief summary
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
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.
Interventions
DEVICEgoLITE
goLITE at 30 minutes per day, within 30 minutes of waking in the morning
DEVICEControl
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, ages 21-64 2. Able and willing to provide written informed consent 3. 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 4. SIGH-ADS score of ≥20 5. 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
1. 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 2. Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator. 3. Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test 4. History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely 5. History or current diagnosis of Bipolar I Disorder 6. Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect 7. History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism) 8. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria 9. Positive urine drug screen at the Physical Screening 10. Active suicidal or homicidal ideation or plan, as determined by the investigator 11. Global Assessment of Functioning (GAF) \<51 (see Appendix B) 12. Use of light therapy treatment within the previous 6 months or any history of goLITE use 13. 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 14. Current use or use within 2 months of antidepressants or mood stabilizing medications, even if taken for a non-psychiatric indication 15. Currently working night shift or rotating shift or other habitual alteration of the sleep/wake cycle 16. Planned travel outside of the state in which the trial is being conducted 17. 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) 18. 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 19. Ishihara score of \<10 on the Ishihara Test for Color Deficiency 20. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SIGH-ADS Score | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SIGH-ADS Score (Week 1 Thru 5) | weekly, from Week 1 through week 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. |
| Q-LES-Q-SF | 6 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | goLITE | Total | Control |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 11.1 | 44.0 years STANDARD_DEVIATION 12.2 | 38.9 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 34 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 32 Participants | 15 Participants |
| Region of Enrollment United States | 18 participants | 35 participants | 17 participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 18 | 9 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| goLITE | SIGH-ADS Score | Baseline | 29.4 units on a scale | Standard Deviation 5.3 |
| goLITE | SIGH-ADS Score | Week 6 | 5.6 units on a scale | Standard Deviation 6.1 |
| Control | SIGH-ADS Score | Baseline | 25.8 units on a scale | Standard Deviation 5.1 |
| Control | SIGH-ADS Score | Week 6 | 4.5 units on a scale | Standard Deviation 5.3 |
Comparison: To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.p-value: 0.74ANOVA
p-value: 0.9ANOVA
p-value: <0.0001ANOVA
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| goLITE | Q-LES-Q-SF | Baseline | 42.5 units on a scale | Standard Deviation 7.1 |
| goLITE | Q-LES-Q-SF | Week 3 | 51.1 units on a scale | Standard Deviation 6.3 |
| goLITE | Q-LES-Q-SF | Week 6 | 55.3 units on a scale | Standard Deviation 9.9 |
| Control | Q-LES-Q-SF | Baseline | 43.6 units on a scale | Standard Deviation 6.4 |
| Control | Q-LES-Q-SF | Week 3 | 52.2 units on a scale | Standard Deviation 7.3 |
| Control | Q-LES-Q-SF | Week 6 | 57.0 units on a scale | Standard Deviation 7.8 |
p-value: 0.2ANOVA
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.
Time frame: weekly, from Week 1 through week 5
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| goLITE | SIGH-ADS Score (Week 1 Thru 5) | Week 2 | 14.4 units on a scale | Standard Deviation 8.7 |
| goLITE | SIGH-ADS Score (Week 1 Thru 5) | Week 4 (phone call) | 10.2 units on a scale | Standard Deviation 7.4 |
| goLITE | SIGH-ADS Score (Week 1 Thru 5) | Week 3 | 12.1 units on a scale | Standard Deviation 7 |
| goLITE | SIGH-ADS Score (Week 1 Thru 5) | Week 5 (phone call) | 7.6 units on a scale | Standard Deviation 5.9 |
| goLITE | SIGH-ADS Score (Week 1 Thru 5) | Week 1 | 17.3 units on a scale | Standard Deviation 9.6 |
| Control | SIGH-ADS Score (Week 1 Thru 5) | Week 5 (phone call) | 5.5 units on a scale | Standard Deviation 5.6 |
| Control | SIGH-ADS Score (Week 1 Thru 5) | Week 1 | 16.9 units on a scale | Standard Deviation 7.5 |
| Control | SIGH-ADS Score (Week 1 Thru 5) | Week 2 | 13.7 units on a scale | Standard Deviation 8.3 |
| Control | SIGH-ADS Score (Week 1 Thru 5) | Week 3 | 9.3 units on a scale | Standard Deviation 8.6 |
| Control | SIGH-ADS Score (Week 1 Thru 5) | Week 4 (phone call) | 6.7 units on a scale | Standard Deviation 6.5 |