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Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blue enriched light with a low intensity
standard light treatment
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring Seasonal Affective Disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, low intensity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard light treatment

    blue enriched light

    Arm Description

    standard light treatment 5000K; 10 000 lux

    Blue enriched light with a low intensity (750 lux)

    Outcomes

    Primary Outcome Measures

    SIGH-SAD
    Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2010
    Last Updated
    August 9, 2011
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01149135
    Brief Title
    Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder
    Official Title
    Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seasonal Affective Disorder
    Keywords
    Seasonal Affective Disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, low intensity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard light treatment
    Arm Type
    Active Comparator
    Arm Description
    standard light treatment 5000K; 10 000 lux
    Arm Title
    blue enriched light
    Arm Type
    Experimental
    Arm Description
    Blue enriched light with a low intensity (750 lux)
    Intervention Type
    Device
    Intervention Name(s)
    Blue enriched light with a low intensity
    Other Intervention Name(s)
    Blue enriched light treatment, Philips energy light HF 3309, 2 lamps PLL36 W 17000 K
    Intervention Description
    30 minutes in the morning, 750 lux
    Intervention Type
    Device
    Intervention Name(s)
    standard light treatment
    Other Intervention Name(s)
    Philips Energylight HF 3309, 2 lamps PLL36 W, color 5000K, 10 000 lux
    Intervention Description
    standard light treatment, 30 minutes, 10 000 lux
    Primary Outcome Measure Information:
    Title
    SIGH-SAD
    Description
    Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version
    Time Frame
    weekly

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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    Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder

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