Clinical Trial: Environmental Treatment for Seasonal Affective Disorder (SAD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Yale University

Current Primary Outcome: 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



Original Primary Outcome: SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD version

Current Secondary Outcome: 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.


Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: August 29, 2005
Date Started: January 2002
Date Completion:
Last Updated: January 29, 2013
Last Verified: January 2013