Environmental Treatment for Seasonal Affective Disorder (SAD)

Yale University26 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Seasonal Affective Disorder

Interventions

Litebook treatment devicesDEVICE

Litebook LED phototherapy device used for 30 min before 8 am

Inactivated negative ion generatorDEVICE

Equivalent exposure to inactivated negative ion generator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Yale University School of Medicine

New Haven, Connecticut, United States

University of British Columbia

Vancouver, British Columbia, Canada

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

Ottawa, Ontario, Canada

Douglas Hospital Research Centre

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: Week 4

Secondary Outcomes

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.

Time frame: Weekly following randomization

Data from ClinicalTrials.gov

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