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

This study has been completed.
Sponsor:
Collaborators:
The Litebook Company Ltd
University of British Columbia
McGill University Health Center
Harvard University
University of Toronto
Clinical Associates Research, Maryland
Dalhousie University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00809523
First received: December 16, 2008
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Seasonal Affective Disorder
Device: Negative Ion Generator
Device: Light-emitting Photodiode light treatment device
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percentage Change SIGH SAD Depression Rating [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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:
  • SIGH SAD Depression Rating [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization and at 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 106
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809523

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06504
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
United States, Massachusetts
McLean Hospital/Harvard
Belmont, Massachusetts, United States, 02478
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1
Canada, New Brunswick
St. John Regional Hospital
St. John, New Brunswick, Canada, E2l 4L2
Canada, Ontario
CAMH/University of Toronto
Toronto, Ontario, Canada, M5T 1R8
Sleep and Alertness Inc
Toronto, Ontario, Canada
Netherlands
University Medical Center Groningen
Groningen, RB, Netherlands, 9700
Sponsors and Collaborators
Yale University
The Litebook Company Ltd
University of British Columbia
McGill University Health Center
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
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00809523     History of Changes
Other Study ID Numbers: 0810004322
Study First Received: December 16, 2008
Results First Received: September 7, 2012
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
SAD
winter depression

Additional relevant MeSH terms:
Seasonal Affective Disorder
Mood Disorders
Depressive Disorder
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014