Environmental Treatment for Seasonal Affective Disorder (SAD)

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Device: Litebook treatment devices; Device: Inactivated negative ion generator

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2A1
      • University of British Columbia
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
  • Quebec
    • Montreal, Quebec, Canada, H4H 1R3
      • Douglas Hospital Research Centre
• Netherlands
  • RB
    • Groningen, RB, Netherlands, 9700
      • University Medical Center Groningen
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of British Columbia; University Medical Center Groningen; Royal Ottawa Mental Health Centre; Douglas Hospital Research Centre
• Investigators: Principal Investigator: Paul H. Desan, PhD, MD, Yale New Haven Hospital

Publications and helpful links

General Publications

• Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: August 29, 2005
• First Submitted That Met QC Criteria: August 29, 2005
• First Posted (Estimate): August 31, 2005

Study Record Updates

• Last Update Posted (Estimate): March 6, 2013
• Last Update Submitted That Met QC Criteria: January 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Major Depression; Seasonal Affective Disorder (SAD)
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Depressive Disorder; Disease; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: 22,777 (Other Identifier: Yale University)