Back to results

Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)

Primary Purpose

Seasonal Affective Disorder

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Original Energy Light,

Original Energy Light prototype

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, Primary disease: Seasonal Affective Disorder, winter type

Eligibility Criteria

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

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

Sites / Locations

Department of Psychiatry, University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Standard Light Treatment

Blue enriched Light treatment 20 min

Blue enriched light treatment 30 min

Arm Description

30 min of Standard bright light treatment (color 5000K)

20 minutes of Blue enriched light treatment (color 17000K)

30 minutes of Blue enriched light treatment (color 17000K)

Outcomes

Primary Outcome Measures

SIGH SAD depression observer rating

Secondary Outcome Measures

selfrating of depressive mood

Full Information

NCT ID

NCT01048294

First Posted

January 12, 2010

Last Updated

January 12, 2010

Sponsor

University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT01048294

Brief Title

Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)

Official Title

Gerandomiseerde en Gecontroleerde Studie Naar de Effecten Van Lichttoediening Met Een Hogere Kleurtemperatuur in Vergelijking Met de Standaard Lichttherapie in de Behandeling Van Winterdepressie

Study Type

Interventional

2. Study Status

Record Verification Date

October 2005

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Medical Center Groningen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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, Primary disease: Seasonal Affective Disorder, winter type

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Light Treatment

Arm Type

Active Comparator

Arm Description

30 min of Standard bright light treatment (color 5000K)

Arm Title

Blue enriched Light treatment 20 min

Arm Type

Experimental

Arm Description

20 minutes of Blue enriched light treatment (color 17000K)

Arm Title

Blue enriched light treatment 30 min

Arm Type

Experimental

Arm Description

30 minutes of Blue enriched light treatment (color 17000K)

Intervention Type

Device

Intervention Name(s)

Original Energy Light,

Other Intervention Name(s)

Philips energy light HF 3308; 2 lamps PLL36W color 5000K

Intervention Description

9000 lux, 30 minutes in the morning

Intervention Type

Device

Intervention Name(s)

Original Energy Light prototype

Other Intervention Name(s)

Philips energy light HF 3308; 2 lamps PLL36W color 17000K

Intervention Description

9000 lux 20 minutes in the morning

Intervention Type

Device

Intervention Name(s)

Original Energy Light prototype

Other Intervention Name(s)

Philips energy light HF 3308; 2 lamps PLL36W color 17000K

Intervention Description

9000 lux 30 minutes in the morning

Primary Outcome Measure Information:

Title

SIGH SAD depression observer rating

Time Frame

days 1, 8, 15, 22

Secondary Outcome Measure Information:

Title

selfrating of depressive mood

Time Frame

once daily during 22 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Y. Meesters, PhD

Organizational Affiliation

Department of Psychiatry, University Medical Center Groningen, The Netherlands

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Psychiatry, University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700RB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

21911257

Citation

Gordijn MCM, 't Mannetje D, Meesters Y. The effects of blue-enriched light treatment compared to standard light treatment in Seasonal Affective Disorder. J Affect Disord. 2012 Jan;136(1-2):72-80. doi: 10.1016/j.jad.2011.08.016. Epub 2011 Sep 10.

Results Reference

derived

Learn more about this trial

Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)

We'll reach out to this number within 24 hrs