- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01149135
Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder
August 9, 2011 updated by: University Medical Center Groningen
Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Standard light treatment
standard light treatment 5000K; 10 000 lux
|
standard light treatment, 30 minutes, 10 000 lux
Other Names:
|
|
EXPERIMENTAL: blue enriched light
Blue enriched light with a low intensity (750 lux)
|
30 minutes in the morning, 750 lux
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SIGH-SAD
Time Frame: weekly
|
Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version
|
weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
March 1, 2009
Study Registration Dates
First Submitted
June 22, 2010
First Submitted That Met QC Criteria
June 22, 2010
First Posted (ESTIMATE)
June 23, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 10, 2011
Last Update Submitted That Met QC Criteria
August 9, 2011
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METc 2008.184
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seasonal Affective Disorder
-
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GlaxoSmithKlineCompleted
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University of OuluCompletedSeasonal Affective Disorder (SAD)Finland
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University of VermontNational Institute of Mental Health (NIMH)CompletedSeasonal Affective Disorder (SAD) | Winter Depression | Major Depressive Disorder, Recurrent, With Seasonal PatternUnited States
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University Medical Center GroningenCompletedSeasonal Affective DisorderNetherlands
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Medical University of ViennaCompletedSeasonal Affective DisorderAustria
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University of VermontUniversity of Maryland, Baltimore; University of PittsburghCompletedSeasonal Affective DisorderUnited States
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Clinical Trials on standard light treatment
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Hangzhou Normal UniversityUnknown
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