A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 106
- Locations
- 8
- Primary Endpoint
- Percentage Change SIGH SAD Depression Rating
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Inactivated negative ion generator
Equivalent exposure to inactivated Negative Ion Generator
Intervention: Negative Ion Generator (Device)
LED light treatment device
Light-emitting photodiode light treatment device, used for 30 min before 8 am
Intervention: Light-emitting Photodiode light treatment device (Device)
Outcomes
Primary Outcomes
Percentage Change SIGH SAD Depression Rating
Time Frame: 4 weeks
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 Outcomes
- SIGH SAD Depression Rating(Weekly)
- Clinical Global Impression of Severity(Randomization and at 4 weeks)