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

Phase 2

Completed

• Conditions: Seasonal Affective Disorder
• Interventions: Device: Light-emitting Photodiode light treatment device; Device: Negative Ion Generator

• Registration Number: NCT00809523
• Lead Sponsor: Yale University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2012-09-07
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-29
• Last Update Submitted: 2013-01-29
• Results First Posted: 2013-03-06
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Seasonal Affective Disorder
• Age 18 to 65

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Exclusion Criteria

• Psychotropic medication treatment
• History of light treatment for SAD
• History of mania or psychosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LED light treatment device	Light-emitting Photodiode light treatment device	Light-emitting photodiode light treatment device, used for 30 min before 8 am
Inactivated negative ion generator	Negative Ion Generator	Equivalent exposure to inactivated Negative Ion Generator

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (8)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

St. John Regional Hospital; 🇨🇦 St. John, New Brunswick, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

CAMH/University of Toronto; 🇨🇦 Toronto, Ontario, Canada

McLean Hospital/Harvard; 🇺🇸 Belmont, Massachusetts, United States

Capital Clinical Research Associates; 🇺🇸 Rockville, Maryland, United States

Sleep and Alertness Inc; 🇨🇦 Toronto, Ontario, Canada

University Medical Center Groningen; 🇳🇱 Groningen, RB, Netherlands