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A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Negative Ion Generator
Light-emitting Photodiode light treatment device
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 SAD, winter depression

Eligibility Criteria

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

Inclusion Criteria:

  • Seasonal Affective Disorder
  • Age 18 to 65

Exclusion Criteria:

  • Psychotropic medication treatment
  • History of light treatment for SAD
  • History of mania or psychosis

Sites / Locations

  • Yale University School of Medicine
  • Capital Clinical Research Associates
  • McLean Hospital/Harvard
  • University of British Columbia
  • St. John Regional Hospital
  • CAMH/University of Toronto
  • Sleep and Alertness Inc
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inactivated negative ion generator

LED light treatment device

Arm Description

Equivalent exposure to inactivated Negative Ion Generator

Light-emitting photodiode light treatment device, used for 30 min before 8 am

Outcomes

Primary Outcome Measures

Percentage Change SIGH SAD Depression Rating
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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization

Secondary Outcome Measures

SIGH SAD Depression Rating
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.
Clinical Global Impression of Severity
The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.

Full Information

First Posted
December 16, 2008
Last Updated
January 29, 2013
Sponsor
Yale University
Collaborators
The Litebook Company Ltd., University of British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Harvard University, University of Toronto, Clinical Associates Research, Maryland, Dalhousie University
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1. Study Identification

Unique Protocol Identification Number
NCT00809523
Brief Title
A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy 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 (SAD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
The Litebook Company Ltd., University of British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Harvard University, University of Toronto, Clinical Associates Research, Maryland, Dalhousie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.
Detailed Description
This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
SAD, winter depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactivated negative ion generator
Arm Type
Experimental
Arm Description
Equivalent exposure to inactivated Negative Ion Generator
Arm Title
LED light treatment device
Arm Type
Experimental
Arm Description
Light-emitting photodiode light treatment device, used for 30 min before 8 am
Intervention Type
Device
Intervention Name(s)
Negative Ion Generator
Intervention Description
Equivalent exposure to inactivated Negative Ion Generator
Intervention Type
Device
Intervention Name(s)
Light-emitting Photodiode light treatment device
Intervention Description
Light-emitting Photodiode light treatment device, used for 30 min before 8 am
Primary Outcome Measure Information:
Title
Percentage Change SIGH SAD Depression Rating
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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SIGH SAD Depression Rating
Description
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
Title
Clinical Global Impression of Severity
Description
The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.
Time Frame
Randomization and at 4 weeks

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: Seasonal Affective Disorder Age 18 to 65 Exclusion Criteria: Psychotropic medication treatment History of light treatment for SAD History of mania or psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Desan, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond Lam, MD
Organizational Affiliation
University of British Columbia, Vancouver, Canada
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
Capital Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
McLean Hospital/Harvard
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
St. John Regional Hospital
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2l 4L2
Country
Canada
Facility Name
CAMH/University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
Facility Name
Sleep and Alertness Inc
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Medical Center Groningen
City
Groningen
State/Province
RB
ZIP/Postal Code
9700
Country
Netherlands

12. IPD Sharing Statement

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A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

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