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

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Seasonal Affective Disorder

Treatments: Device: Light-emitting Photodiode light treatment device; Device: Negative Ion Generator

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00809523

0810004322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Inactivated negative ion generator

Experimental group

Description:

Equivalent exposure to inactivated Negative Ion Generator

Treatment:

Device: Negative Ion Generator

LED light treatment device

Experimental group

Description:

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

Treatment:

Device: Light-emitting Photodiode light treatment device