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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01149135
Other study ID # METc 2008.184
Secondary ID
Status Completed
Phase N/A
First received June 22, 2010
Last updated August 9, 2011
Start date October 2008
Est. completion date March 2009

Study information

Verified date October 2008
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: Ministry of Health, Welfare and Sport
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Blue enriched light with a low intensity
30 minutes in the morning, 750 lux
standard light treatment
standard light treatment, 30 minutes, 10 000 lux

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Outcome

Type Measure Description Time frame Safety issue
Primary SIGH-SAD Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version weekly No
See also
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Active, not recruiting NCT03691792 - Optimizing Long-Term Outcomes for Winter Depression With CBT-SAD and Light Therapy N/A
Completed NCT01462058 - The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff Phase 4
Recruiting NCT01030276 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Completed NCT01292889 - Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder N/A
Completed NCT01048294 - Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD) N/A
Completed NCT02582398 - Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET N/A
Completed NCT01293409 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Active, not recruiting NCT00269633 - Research Study of Treatment for Winter Depression With Different Colors of Light Phase 2
Completed NCT00076245 - Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD) Phase 1
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Completed NCT00001485 - Effects of Season on Melatonin Secretion in Healthy Men and Women and Patients With Seasonal Affective Disorder N/A
Completed NCT01462305 - 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder N/A
Completed NCT00139997 - Environmental Treatment for Seasonal Affective Disorder (SAD) N/A
Completed NCT04251000 - Infrared Photomodulation Therapy for Seasonal Affective Disorder N/A
Completed NCT00809523 - A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD) Phase 2/Phase 3