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NCT Number: NCT00809523

A 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.

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Key information

Conditions

Seasonal Affective Disorder Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Ion Generator

Device

Equivalent exposure to inactivated Negative Ion Generator

Light-emitting Photodiode light treatment device

Device

Light-emitting Photodiode light treatment device, used for 30 min before 8 am

Primary outcomes

  1. Percentage Change SIGH SAD Depression Rating

    Time frame: 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 outcomes

  1. SIGH SAD Depression Rating

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2008
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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