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

This study is currently recruiting participants.

Verified by Yale University, December 2008

Sponsors and Collaborators:	Yale University University of British Columbia McGill University Health Center Harvard University The University of New South Wales University of Toronto Clinical Associates Research, Maryland
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00809523

Purpose

This is a randomized, controlled clinical trial of 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.

Condition	Intervention	Phase
Seasonal Affective Disorder	Device: Negative Ion Generator Device: Light-emitting Photodiode light treatment device	Phase II Phase III

MedlinePlus related topics: Depression Seasonal Affective Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

Further study details as provided by Yale University:

Primary Outcome Measures:

SIGH SAD Depression rating [ Time Frame: after 0, 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression [ Time Frame: after 1, 1, 2, 3 and 4 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Negative Ion Generator	Device: Negative Ion Generator Negative Ion Generator
2: Experimental Light-emitting photodiode light treatment device	Device: Light-emitting Photodiode light treatment device Light-emitting Photodiode light treatment device

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809523

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06504
Contact: Paul Desan, MD, PhD 203-785-2088
Principal Investigator: Paul Desan, MD, PhD

Sponsors and Collaborators

Yale University

University of British Columbia

McGill University Health Center

Harvard University

The University of New South Wales

University of Toronto

Clinical Associates Research, Maryland

Investigators

Principal Investigator:

Paul Desan, MD, PhD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Paul Desan, MD, PhD )
Study ID Numbers:	0810004322
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809523
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

SAD
winter depression

Study placed in the following topic categories:

Seasonal Affective Disorder
Depression
Mental Disorders
Mood Disorders
Depressive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009