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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Week 4

Results posted on

2013-03-06

Participant Flow

Participant milestones

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

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 4

Population: 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

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 randomization

Population: 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

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

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Inactive Intervention

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Paul Desan, MD, PhD

Yale University

Phone: 203 785 2618

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place