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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Device: Negative Ion Generator; Device: Light-emitting Photodiode light treatment device

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2A1
      • University of British Columbia
  • New Brunswick
    • St. John, New Brunswick, Canada, E2L 4L2
      • St. John Regional Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • CAMH/University of Toronto
    • Toronto, Ontario, Canada
      • Sleep and Alertness Inc
• Netherlands
  • RB
    • Groningen, RB, Netherlands, 9700
      • University Medical Center Groningen
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale University School of Medicine
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Capital Clinical Research Associates
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital/Harvard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of British Columbia; McGill University Health Centre/Research Institute of the McGill University Health Centre; University of Toronto; Dalhousie University; Harvard University; The Litebook Company Ltd.; Clinical Associates Research, Maryland
• Investigators: Principal Investigator: Paul Desan, MD, PhD, Yale University; Principal Investigator: Raymond Lam, MD, University of British Columbia, Vancouver, Canada

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 6, 2013
• Last Update Submitted That Met QC Criteria: January 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: SAD; winter depression
• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: 0810004322