Environmental Treatment for Seasonal Affective Disorder (SAD)

Study Overview
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Brief Summary
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The purpose is to study treatments of Seasonal Affective Disorder (SAD).

Detailed Description
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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.

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

Conditions
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Seasonal Affective Disorder

Intervention / Treatment
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* Device: Litebook treatment devices
* Device: Inactivated negative ion generator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LED phototherapy device<br>Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am | Device: Litebook treatment devices<br>* Litebook LED phototherapy device used for 30 min before 8 am<br>|
| Placebo Comparator: Inactivated Negative Ion Generator<br>Equivalent exposure to inactivated negative ion generator | Device: Inactivated negative ion generator<br>* Equivalent exposure to inactivated negative ion generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | 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 | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version | 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. | Weekly following randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Seasonal Affective Disorder (SAD)