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

Seasonal Affective Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048294
• Other study ID #: METc2005/160
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: October 2005
• Est. completion date: March 2006

Study information

• Verified date: October 2005
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Device:
• Original Energy Light,
9000 lux, 30 minutes in the morning
• Original Energy Light prototype
9000 lux 20 minutes in the morning
• Original Energy Light prototype
9000 lux 30 minutes in the morning

Locations

Country	Name	City	State
Netherlands	Department of Psychiatry, University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIGH SAD depression observer rating		days 1, 8, 15, 22	No
Secondary	selfrating of depressive mood		once daily during 22 days	No