- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048294
Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)
January 12, 2010 updated by: University Medical Center Groningen
Gerandomiseerde en Gecontroleerde Studie Naar de Effecten Van Lichttoediening Met Een Hogere Kleurtemperatuur in Vergelijking Met de Standaard Lichttherapie in de Behandeling Van Winterdepressie
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9700RB
- Department of Psychiatry, University Medical Center Groningen
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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;
- 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
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Light Treatment
30 min of Standard bright light treatment (color 5000K)
|
9000 lux, 30 minutes in the morning
Other Names:
|
Experimental: Blue enriched Light treatment 20 min
20 minutes of Blue enriched light treatment (color 17000K)
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9000 lux 20 minutes in the morning
Other Names:
9000 lux 30 minutes in the morning
Other Names:
|
Experimental: Blue enriched light treatment 30 min
30 minutes of Blue enriched light treatment (color 17000K)
|
9000 lux 20 minutes in the morning
Other Names:
9000 lux 30 minutes in the morning
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SIGH SAD depression observer rating
Time Frame: days 1, 8, 15, 22
|
days 1, 8, 15, 22
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
selfrating of depressive mood
Time Frame: once daily during 22 days
|
once daily during 22 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Y. Meesters, PhD, Department of Psychiatry, University Medical Center Groningen, The Netherlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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, 2005
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Estimate)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METc2005/160
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.
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