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

NCT ID: NCT00809523

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-04-30

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.

Conditions

Seasonal Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Inactivated negative ion generator

Equivalent exposure to inactivated Negative Ion Generator

Group Type: EXPERIMENTAL

Negative Ion Generator

Intervention Type: DEVICE

Equivalent exposure to inactivated Negative Ion Generator

LED light treatment device

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

Group Type: EXPERIMENTAL

Light-emitting Photodiode light treatment device

Intervention Type: DEVICE

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

Interventions

Negative Ion Generator

Equivalent exposure to inactivated Negative Ion Generator

Intervention Type: DEVICE

Light-emitting Photodiode light treatment device

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Litebook Company Ltd.

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Clinical Associates Research, Maryland

NETWORK

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Desan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Raymond Lam, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Vancouver, Canada

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Capital Clinical Research Associates

Rockville, Maryland, United States

McLean Hospital/Harvard

Belmont, Massachusetts, United States

University of British Columbia

Vancouver, British Columbia, Canada

St. John Regional Hospital

Saint John, New Brunswick, Canada

CAMH/University of Toronto

Toronto, Ontario, Canada

Sleep and Alertness Inc

Toronto, Ontario, Canada

University Medical Center Groningen

Groningen, RB, Netherlands

Countries

United States; Canada; Netherlands

Other Identifiers

0810004322

Identifier Type: -

Identifier Source: org_study_id