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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00809523
• Collaborator: The Litebook Company Ltd. (Industry), University of British Columbia (Other), McGill University Health Centre/Research Institute of the McGill University Health Centre (Other), Harvard University (Other), University of Toronto (Other), Clinical Associates Research, Maryland (Other), Dalhousie University (Other)
• Enrollment: 106
• Locations: 8
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Affective Disorder	Device: Negative Ion Generator; Device: Light-emitting Photodiode light treatment device	Phase 2/Phase 3

Detailed Description

This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inactivated negative ion generator Equivalent exposure to inactivated Negative Ion Generator	Device: Negative Ion Generator; Equivalent exposure to inactivated Negative Ion Generator
Experimental: LED light treatment device Light-emitting photodiode light treatment device, used for 30 min before 8 am	Device: Light-emitting Photodiode light treatment device; Light-emitting Photodiode light treatment device, used for 30 min before 8 am

Outcome Measures

Primary Outcome Measures

1. Percentage Change SIGH SAD Depression Rating [4 weeks]

   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

Secondary Outcome Measures

1. SIGH SAD Depression Rating [Weekly]

   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.

2. Clinical Global Impression of Severity [Randomization and at 4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Seasonal Affective Disorder

• Age 18 to 65

Exclusion Criteria:

• Psychotropic medication treatment

• History of light treatment for SAD

• History of mania or psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06504
2	Capital Clinical Research Associates	Rockville	Maryland	United States	20852
3	McLean Hospital/Harvard	Belmont	Massachusetts	United States	02478
4	University of British Columbia	Vancouver	British Columbia	Canada	V6T 2A1
5	St. John Regional Hospital	St. John	New Brunswick	Canada	E2l 4L2
6	CAMH/University of Toronto	Toronto	Ontario	Canada	M5T 1R8
7	Sleep and Alertness Inc	Toronto	Ontario	Canada
8	University Medical Center Groningen	Groningen	RB	Netherlands	9700

Sponsors and Collaborators

• Yale University
• The Litebook Company Ltd.
• University of British Columbia
• McGill University Health Centre/Research Institute of the McGill University Health Centre
• Harvard University
• University of Toronto
• Clinical Associates Research, Maryland
• Dalhousie University

Investigators

• Principal Investigator: Paul Desan, MD, PhD, Yale University
• Principal Investigator: Raymond Lam, MD, University of British Columbia, Vancouver, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00809523
• Other Study ID Numbers: 0810004322
• First Posted: Dec 17, 2008
• Last Update Posted: Mar 6, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Yale University: SAD; winter depression
• Additional relevant MeSH terms: Mood Disorders; Seasonal Affective Disorder

Study Results

Participant Flow

Arm/Group Title	Inactivated Negative Ion Generator	LED Phototherapy Device
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator	Light-emitting photodiode light treatment device, used for 30 min before 8 am
Period Title: Overall Study
STARTED	54	52
COMPLETED	47	48
NOT COMPLETED	7	4

Baseline Characteristics

Arm/Group Title	Inactivated Negative Ion Generator	LED Phototherapy Device	Total
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator	Light-emitting photodiode light treatment device, used for 30 min before 8 am	Total of all reporting groups
Overall Participants	54	52	106
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	54 100%	52 100%	106 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	42 77.8%	38 73.1%	80 75.5%
Male	12 22.2%	14 26.9%	26 24.5%
Region of Enrollment (participants) [Number]
United States	20 37%	18 34.6%	38 35.8%
Netherlands	8 14.8%	9 17.3%	17 16%
Canada	26 48.1%	25 48.1%	51 48.1%

Outcome Measures

1. Secondary Outcome

Title	SIGH SAD Depression Rating
Description	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.
Time Frame	Weekly

Outcome Measure Data

Analysis Population Description

Intent to treat analysis last observation carried forward.

Arm/Group Title	Inactivated Negative Ion Generator	LED Phototherapy Device
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator	Light-emitting photodiode light treatment device, used for 30 min before 8 am
Measure Participants	54	52
Randomization	28.6 (6.7)	27.7 (4.8)
Week 1	23.6 (8.7)	20.9 (7.0)
Week 2	19.9 (9.3)	17.4 (7.8)
Week 3	18.6 (9.7)	15.8 (8.3)
Week 4	17.9 (10.2)	13.3 (9.2)

2. Secondary Outcome

Title	Clinical Global Impression of Severity
Description	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.
Time Frame	Randomization and at 4 weeks

Outcome Measure Data

Analysis Population Description

intent to treat analysis

Arm/Group Title	Inactivated Negative Ion Generator	LED Phototherapy Device
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator	Light-emitting photodiode light treatment device, used for 30 min before 8 am
Measure Participants	54	52
Randomization	4.2 (0.6)	4.2 (0.7)
Week 4	3.0 (1.3)	2.4 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inactivated Negative Ion Generator, LED Phototherapy Device
	Comments	Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Percentage Change SIGH SAD Depression Rating
Description	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
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat analysis last observation carried forward.

Arm/Group Title	Inactivated Negative Ion Generator	LED Phototherapy Device
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator	Light-emitting photodiode light treatment device, used for 30 min before 8 am
Measure Participants	54	52
Mean (Standard Deviation) [percentage of change on SIGH SAD]	-36.4 (34.9)	-52.7 (31.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inactivated Negative Ion Generator, LED Phototherapy Device
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Inactivated Negative Ion Generator		LED Phototherapy Device
Arm/Group Description	Equivalent exposure to inactivated Negative Ion Generator		Light-emitting photodiode light treatment device, used for 30 min before 8 am
All Cause Mortality
	Inactivated Negative Ion Generator		LED Phototherapy Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Inactivated Negative Ion Generator		LED Phototherapy Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Inactivated Negative Ion Generator		LED Phototherapy Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/54 (1.9%)		7/52 (13.5%)
Nervous system disorders
Eye strain/glare	0/54 (0%)	0	3/52 (5.8%)	3
headache	1/54 (1.9%)	1	5/52 (9.6%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.