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Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder

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ClinicalTrials.gov Identifier: NCT01149135
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE June 23, 2010
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
SIGH-SAD [ Time Frame: weekly ]
Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder
Official Title  ICMJE Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Affective Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard light treatment
    standard light treatment 5000K; 10 000 lux
    Intervention: Device: standard light treatment
  • Experimental: blue enriched light
    Blue enriched light with a low intensity (750 lux)
    Intervention: Device: Blue enriched light with a low intensity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2010)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01149135
Other Study ID Numbers  ICMJE METc 2008.184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ybe Meesters PhD, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Center Groningen
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP