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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01048294
First received: January 12, 2010
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Seasonal Affective Disorder
Device: Original Energy Light,
Device: Original Energy Light prototype

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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • SIGH SAD depression observer rating [ Time Frame: days 1, 8, 15, 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • selfrating of depressive mood [ Time Frame: once daily during 22 days ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Light Treatment
30 min of Standard bright light treatment (color 5000K)
Device: Original Energy Light,
9000 lux, 30 minutes in the morning
Other Name: Philips energy light HF 3308; 2 lamps PLL36W color 5000K
Experimental: Blue enriched Light treatment 20 min
20 minutes of Blue enriched light treatment (color 17000K)
Device: Original Energy Light prototype
9000 lux 20 minutes in the morning
Other Name: Philips energy light HF 3308; 2 lamps PLL36W color 17000K
Experimental: Blue enriched light treatment 30 min
30 minutes of Blue enriched light treatment (color 17000K)
Device: Original Energy Light prototype
9000 lux 30 minutes in the morning
Other Name: Philips energy light HF 3308; 2 lamps PLL36W color 17000K

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01048294

Locations
Netherlands
Department of Psychiatry, University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Study Chair: Y. Meesters, PhD Department of Psychiatry, University Medical Center Groningen, The Netherlands
  More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ybe Meesters, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01048294     History of Changes
Other Study ID Numbers: METc2005/160
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by University Medical Centre Groningen:
Seasonal affective disorder
phototherapy
circadian rhythms
blue enriched light
melanopsin
Primary disease: Seasonal Affective Disorder, winter type

Additional relevant MeSH terms:
Seasonal Affective Disorder
Mood Disorders
Depressive Disorder
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014