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Environmental Treatment for Seasonal Affective Disorder (SAD)

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Litebook treatment devices
Inactivated negative ion generator
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring Major Depression, Seasonal Affective Disorder (SAD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University School of Medicine
  • University of British Columbia
  • Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
  • Douglas Hospital Research Centre
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LED phototherapy device

Inactivated Negative Ion Generator

Arm Description

Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am

Equivalent exposure to inactivated negative ion generator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2005
Last Updated
January 29, 2013
Sponsor
Yale University
Collaborators
University Medical Center Groningen, University of British Columbia, Royal Ottawa Mental Health Centre, Douglas Hospital Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00139997
Brief Title
Environmental Treatment for Seasonal Affective Disorder (SAD)
Official Title
A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University Medical Center Groningen, University of British Columbia, Royal Ottawa Mental Health Centre, Douglas Hospital Research Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
Major Depression, Seasonal Affective Disorder (SAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LED phototherapy device
Arm Type
Experimental
Arm Description
Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am
Arm Title
Inactivated Negative Ion Generator
Arm Type
Placebo Comparator
Arm Description
Equivalent exposure to inactivated negative ion generator
Intervention Type
Device
Intervention Name(s)
Litebook treatment devices
Intervention Description
Litebook LED phototherapy device used for 30 min before 8 am
Intervention Type
Device
Intervention Name(s)
Inactivated negative ion generator
Intervention Description
Equivalent exposure to inactivated negative ion generator
Primary Outcome Measure Information:
Title
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Description
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 Outcome Measure Information:
Title
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul H. Desan, PhD, MD
Organizational Affiliation
Yale New Haven Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Facility Name
Douglas Hospital Research Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
University Medical Center Groningen
City
Groningen
State/Province
RB
ZIP/Postal Code
9700
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17683643
Citation
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.
Results Reference
result

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Environmental Treatment for Seasonal Affective Disorder (SAD)

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