Trial Outcomes & Findings for A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD) (NCT NCT00809523)

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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

106 participants

Primary outcome timeframe

4 weeks

Results posted on

2013-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Inactivated Negative Ion Generator Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device Light-emitting photodiode light treatment device, used for 30 min before 8 am
Overall Study STARTED	54	52
Overall Study COMPLETED	47	48
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inactivated Negative Ion Generator n=54 Participants Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device n=52 Participants Light-emitting photodiode light treatment device, used for 30 min before 8 am	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=93 Participants	52 Participants n=4 Participants	106 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	38 Participants n=4 Participants	80 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	18 participants n=4 Participants	38 participants n=27 Participants
Region of Enrollment Netherlands	8 participants n=93 Participants	9 participants n=4 Participants	17 participants n=27 Participants
Region of Enrollment Canada	26 participants n=93 Participants	25 participants n=4 Participants	51 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intent to treat analysis 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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization

Outcome measures

Outcome measures
Measure	Inactivated Negative Ion Generator n=54 Participants Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device n=52 Participants Light-emitting photodiode light treatment device, used for 30 min before 8 am
Percentage Change SIGH SAD Depression Rating	-36.4 percentage of change on SIGH SAD Standard Deviation 34.9	-52.7 percentage of change on SIGH SAD Standard Deviation 31.7

SECONDARY outcome

Timeframe: Weekly

Population: Intent to treat analysis last observation carried forward.

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	Inactivated Negative Ion Generator n=54 Participants Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device n=52 Participants Light-emitting photodiode light treatment device, used for 30 min before 8 am
SIGH SAD Depression Rating Randomization	28.6 units on a scale Standard Deviation 6.7	27.7 units on a scale Standard Deviation 4.8
SIGH SAD Depression Rating Week 1	23.6 units on a scale Standard Deviation 8.7	20.9 units on a scale Standard Deviation 7.0
SIGH SAD Depression Rating Week 2	19.9 units on a scale Standard Deviation 9.3	17.4 units on a scale Standard Deviation 7.8
SIGH SAD Depression Rating Week 3	18.6 units on a scale Standard Deviation 9.7	15.8 units on a scale Standard Deviation 8.3
SIGH SAD Depression Rating Week 4	17.9 units on a scale Standard Deviation 10.2	13.3 units on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Randomization and at 4 weeks

Population: intent to treat analysis

The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.

Outcome measures

Outcome measures
Measure	Inactivated Negative Ion Generator n=54 Participants Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device n=52 Participants Light-emitting photodiode light treatment device, used for 30 min before 8 am
Clinical Global Impression of Severity Randomization	4.2 units on a scale Standard Deviation 0.6	4.2 units on a scale Standard Deviation 0.7
Clinical Global Impression of Severity Week 4	3.0 units on a scale Standard Deviation 1.3	2.4 units on a scale Standard Deviation 1.2

Adverse Events

Inactivated Negative Ion Generator

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LED Phototherapy Device

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Inactivated Negative Ion Generator n=54 participants at risk Equivalent exposure to inactivated Negative Ion Generator	LED Phototherapy Device n=52 participants at risk Light-emitting photodiode light treatment device, used for 30 min before 8 am
Nervous system disorders Eye strain/glare	0.00% 0/54	5.8% 3/52 • Number of events 3
Nervous system disorders headache	1.9% 1/54 • Number of events 1	9.6% 5/52 • Number of events 5

Additional Information

Paul Desan, MD, PhD

Yale University

Phone: 203 785 2618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place