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

Seasonal Affective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809523
• Other study ID #: 0810004322
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 16, 2008
• Last updated: January 29, 2013
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Device:
• Negative Ion Generator
Equivalent exposure to inactivated Negative Ion Generator
• Light-emitting Photodiode light treatment device
Light-emitting Photodiode light treatment device, used for 30 min before 8 am

Locations

Country	Name	City	State
Canada	St. John Regional Hospital	St. John	New Brunswick
Canada	CAMH/University of Toronto	Toronto	Ontario
Canada	Sleep and Alertness Inc	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Netherlands	University Medical Center Groningen	Groningen	RB
United States	McLean Hospital/Harvard	Belmont	Massachusetts
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Capital Clinical Research Associates	Rockville	Maryland

Sponsors (8)

Lead Sponsor	Collaborator
Yale University	Clinical Associates Research, Maryland, Dalhousie University, Harvard University, McGill University Health Center, The Litebook Company Ltd., University of British Columbia, University of Toronto

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change SIGH SAD Depression Rating	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	4 weeks	No
Secondary	SIGH SAD Depression Rating	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.	Weekly	No
Secondary	Clinical Global Impression of Severity	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.	Randomization and at 4 weeks	No