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Environmental Treatment for Seasonal Affective Disorder (SAD)

Not Applicable
Completed
Conditions
Seasonal Affective Disorder
Interventions
Device: Litebook treatment devices
Device: Inactivated negative ion generator
Registration Number
NCT00139997
Lead Sponsor
Yale University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LED phototherapy deviceLitebook treatment devicesLitebook treatment devices: LED phototherapy device, used for 30 min before 8 am
Inactivated Negative Ion GeneratorInactivated negative ion generatorEquivalent exposure to inactivated negative ion generator
Primary Outcome Measures
NameTimeMethod
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD VersionWeek 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 Outcome Measures
NameTimeMethod
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD VersionWeekly 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.

Trial Locations

Locations (5)

Douglas Hospital Research Centre

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Montreal, Quebec, Canada

University Medical Center Groningen

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Groningen, RB, Netherlands

University of British Columbia

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Vancouver, British Columbia, Canada

Yale University School of Medicine

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New Haven, Connecticut, United States

Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada

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Ottawa, Ontario, Canada

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