Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01149135
First received: June 22, 2010
Last updated: August 9, 2011
Last verified: October 2008
  Purpose

One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winter depression 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.,In a earlier study it was shown that the therapeutic effect of blue enriched light were equal to standard light treatment using light in both conditions with an intensity of 10 000 lux. In the present study, blue enriched light with an intensity of 750 lux was used, because of the possible saturation effect in the former study. The investigators hypothesise that blue- enriched light with a low intensity 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: Blue enriched light with a low intensity
Device: standard light treatment

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: Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • SIGH-SAD [ Time Frame: weekly ] [ Designated as safety issue: No ]
    Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version


Enrollment: 22
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard light treatment
standard light treatment 5000K; 10 000 lux
Device: standard light treatment
standard light treatment, 30 minutes, 10 000 lux
Other Name: Philips Energylight HF 3309, 2 lamps PLL36 W, color 5000K, 10 000 lux
Experimental: blue enriched light
Blue enriched light with a low intensity (750 lux)
Device: Blue enriched light with a low intensity
30 minutes in the morning, 750 lux
Other Names:
  • Blue enriched light treatment
  • Philips energy light HF 3309, 2 lamps PLL36 W 17000 K

  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
  • Diagnose 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-I disorders according to the DSM-IV
  • Acute suicide risk
  • Use of psychotropic drugs or photosensitizing drugs
  • No other treatments for mood disorder during the study
  • Diabetes or epilepsy
  • Regular shift work
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ybe Meesters PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01149135     History of Changes
Other Study ID Numbers: METc 2008.184
Study First Received: June 22, 2010
Last Updated: August 9, 2011
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
low intensity

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

ClinicalTrials.gov processed this record on September 18, 2014