Trial Outcomes & Findings for 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder (NCT NCT01462305)
NCT ID: NCT01462305
Last Updated: 2019-01-30
Results Overview
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.
COMPLETED
NA
35 participants
6 weeks
2019-01-30
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
Baseline characteristics by cohort
| Measure |
goLITE
n=18 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
|
Control
n=17 Participants
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
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
goLITE
n=18 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
|
Control
n=17 Participants
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
|
|---|---|---|
|
SIGH-ADS Score
Baseline
|
29.4 units on a scale
Standard Deviation 5.3
|
25.8 units on a scale
Standard Deviation 5.1
|
|
SIGH-ADS Score
Week 6
|
5.6 units on a scale
Standard Deviation 6.1
|
4.5 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: weekly, from Week 1 through week 5Population: 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.
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.
Outcome measures
| Measure |
goLITE
n=17 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
|
Control
n=14 Participants
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
|
|---|---|---|
|
SIGH-ADS Score (Week 1 Thru 5)
Week 1
|
17.3 units on a scale
Standard Deviation 9.6
|
16.9 units on a scale
Standard Deviation 7.5
|
|
SIGH-ADS Score (Week 1 Thru 5)
Week 2
|
14.4 units on a scale
Standard Deviation 8.7
|
13.7 units on a scale
Standard Deviation 8.3
|
|
SIGH-ADS Score (Week 1 Thru 5)
Week 3
|
12.1 units on a scale
Standard Deviation 7.0
|
9.3 units on a scale
Standard Deviation 8.6
|
|
SIGH-ADS Score (Week 1 Thru 5)
Week 4 (phone call)
|
10.2 units on a scale
Standard Deviation 7.4
|
6.7 units on a scale
Standard Deviation 6.5
|
|
SIGH-ADS Score (Week 1 Thru 5)
Week 5 (phone call)
|
7.6 units on a scale
Standard Deviation 5.9
|
5.5 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
goLITE
n=15 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
|
Control
n=16 Participants
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
|
|---|---|---|
|
Q-LES-Q-SF
Baseline
|
42.5 units on a scale
Standard Deviation 7.1
|
43.6 units on a scale
Standard Deviation 6.4
|
|
Q-LES-Q-SF
Week 3
|
51.1 units on a scale
Standard Deviation 6.3
|
52.2 units on a scale
Standard Deviation 7.3
|
|
Q-LES-Q-SF
Week 6
|
55.3 units on a scale
Standard Deviation 9.9
|
57.0 units on a scale
Standard Deviation 7.8
|
Adverse Events
goLITE
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
goLITE
n=18 participants at risk
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
|
Control
n=17 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 4 • 6 weeks
|
41.2%
7/17 • Number of events 10 • 6 weeks
|
|
Gastrointestinal disorders
diarrhea
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Drainage
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Nervous system disorders
Sinus Headache
|
5.6%
1/18 • Number of events 2 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Eye disorders
Eye Sensitivity
|
5.6%
1/18 • Number of events 2 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Nervous system disorders
Migraine
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
17.6%
3/17 • Number of events 4 • 6 weeks
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal sinus irritation
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Immune system disorders
cold
|
22.2%
4/18 • Number of events 4 • 6 weeks
|
17.6%
3/17 • Number of events 3 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
backache
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Infections and infestations
sinus infection
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Eye disorders
hot spot on eye
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Eye disorders
eye strain
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
facial warming
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Gastrointestinal disorders
GI upset
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Eye disorders
itchy/watery eyes
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/17 • 6 weeks
|
|
Reproductive system and breast disorders
perimenstrual symptoms
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Eye disorders
white flashing lights
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
bloody nose
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
body aches
|
0.00%
0/18 • 6 weeks
|
17.6%
3/17 • Number of events 3 • 6 weeks
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
insomnia
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/18 • 6 weeks
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place