Phase 3
N=106
A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
Seasonal Affective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00809523 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Percentage Change SIGH SAD Depression Rating — -36.4; -52.7 percentage of change on SIGH SAD — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Negative Ion Generator (Device); Light-emitting Photodiode light treatment device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change SIGH SAD Depression Rating |
-36.4; -52.7 | 0.014 sig |
| SECONDARY SIGH SAD Depression Rating |
28.6; 27.7; 23.6; 20.9; 19.9; 17.4 | — |
| SECONDARY Clinical Global Impression of Severity |
4.2; 4.2; 3.0; 2.4 | 0.007 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00809523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.