Trial Outcomes & Findings for Environmental Treatment for Seasonal Affective Disorder (SAD) (NCT NCT00139997)
NCT ID: NCT00139997
Last Updated: 2013-03-06
Results Overview
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression. Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization
COMPLETED
NA
26 participants
Week 4
2013-03-06
Participant Flow
Participant milestones
| Measure |
LED Phototherapy
Phototherapy with light-emitting diode phototherapy device
|
Inactive Intervention
Equivalent exposure to inactive negative ion generator
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Environmental Treatment for Seasonal Affective Disorder (SAD)
Baseline characteristics by cohort
| Measure |
LED Phototherapy
n=15 Participants
Phototherapy with light-emitting diode phototherapy device
|
Inactive Intervention
n=11 Participants
Equivalent exposure to inactive negative ion generator
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
42.9 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
44.9 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
43.7 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: These participants are analyzed ITT- last observation carried forward.
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression. Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization
Outcome measures
| Measure |
LED Phototherapy
n=15 Participants
Phototherapy with light-emitting diode phototherapy device
|
Inactive Intervention
n=11 Participants
Equivalent exposure to inactive negative ion generator
|
|---|---|---|
|
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
|
34.5 Percentage of SIGH SAD
Standard Deviation 30.47
|
60.4 Percentage of SIGH SAD
Standard Deviation 23.61
|
SECONDARY outcome
Timeframe: Weekly following randomizationPopulation: These participants are analyzed ITT- last observation carried forward.
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.
Outcome measures
| Measure |
LED Phototherapy
n=15 Participants
Phototherapy with light-emitting diode phototherapy device
|
Inactive Intervention
n=11 Participants
Equivalent exposure to inactive negative ion generator
|
|---|---|---|
|
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Randomization
|
28.0 units on a scale
Standard Deviation 5.3
|
25.1 units on a scale
Standard Deviation 3.2
|
|
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Week 1
|
18.6 units on a scale
Standard Deviation 7.9
|
19.0 units on a scale
Standard Deviation 7.2
|
|
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Week 2
|
14.9 units on a scale
Standard Deviation 10.0
|
17.9 units on a scale
Standard Deviation 4.9
|
|
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Week 3
|
11.1 units on a scale
Standard Deviation 10.1
|
14.9 units on a scale
Standard Deviation 4.2
|
|
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Week 4
|
8.7 units on a scale
Standard Deviation 8.4
|
13.4 units on a scale
Standard Deviation 5.4
|
Adverse Events
LED Phototherapy
Inactive Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LED Phototherapy
n=15 participants at risk
Phototherapy with light-emitting diode phototherapy device
|
Inactive Intervention
n=11 participants at risk
Equivalent exposure to inactive negative ion generator
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1
|
0.00%
0/11
|
|
General disorders
dry mouth
|
6.7%
1/15 • Number of events 1
|
0.00%
0/11
|
|
Psychiatric disorders
jitteriness
|
6.7%
1/15 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
difficulty falling asleep
|
6.7%
1/15 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place