Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)

Study Overview
=================
Brief Summary
-----------------
One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients., The investigators hypothesise that blue- enriched light improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.

Official Title
-----------------
Gerandomiseerde en Gecontroleerde Studie Naar de Effecten Van Lichttoediening Met Een Hogere Kleurtemperatuur in Vergelijking Met de Standaard Lichttherapie in de Behandeling Van Winterdepressie

Conditions
-----------------
Seasonal Affective Disorder

Intervention / Treatment
-----------------
* Device: Original Energy Light,
* Device: Original Energy Light prototype
* Device: Original Energy Light prototype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65; diagnosis of Seasonal affective Disorder, winter type according to DSM-IV; SIGH SAD rating higher then or equal to 18 on day 1; no other treatments for mood disorder during the study stay in the Netherlands during the study Exclusion Criteria: other Axis 1 disorder according to DSM-IV acute suicide risk use of psychotropic drugs or photosensitizing drugs eye diseases other then usual effect of aging diabetes or epilepsy regular shift work

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Light Treatment<br>30 min of Standard bright light treatment (color 5000K) | Device: Original Energy Light,<br>* 9000 lux, 30 minutes in the morning<br>* Other names: Philips energy light HF 3308; 2 lamps PLL36W color 5000K;|
| Experimental: Blue enriched Light treatment 20 min<br>20 minutes of Blue enriched light treatment (color 17000K) | Device: Original Energy Light prototype<br>* 9000 lux 20 minutes in the morning<br>* Other names: Philips energy light HF 3308; 2 lamps PLL36W color 17000K;|
| Experimental: Blue enriched light treatment 30 min<br>30 minutes of Blue enriched light treatment (color 17000K) | Device: Original Energy Light prototype<br>* 9000 lux 30 minutes in the morning<br>* Other names: Philips energy light HF 3308; 2 lamps PLL36W color 17000K;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIGH SAD depression observer rating |  | days 1, 8, 15, 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| selfrating of depressive mood |  | once daily during 22 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal affective disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, Primary disease: Seasonal Affective Disorder, winter type