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Completed

NCT Number: NCT00139997

Environmental Treatment for Seasonal Affective Disorder (SAD)

The purpose is to study treatments of Seasonal Affective Disorder (SAD).

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Key information

Conditions

Seasonal Affective Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.

This trial has now been completed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.

Exclusion criteria

  • Significant suicidal risk
  • Serious medical illness
  • Pregnancy
  • Other DSM-IV diagnoses
  • Taking mood altering medication
  • May not travel to a sunny destination during study

Treatment and study plan

Litebook treatment devices

Device

Litebook LED phototherapy device used for 30 min before 8 am

Inactivated negative ion generator

Device

Equivalent exposure to inactivated negative ion generator

Primary outcomes

  1. Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version

    Time frame: Week 4

    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 x 100 / SIGH SAD score at randomization

Secondary outcomes

  1. SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version

    Time frame: Weekly following randomization

    SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Douglas Hospital Research Centre
  • Royal Ottawa Mental Health Centre
  • University Medical Center Groningen
  • University of British Columbia

Registry information

Official study title

A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Aug 31, 2005
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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