NCT01048294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

January 13, 2010

Status Verified

October 1, 2005

Enrollment Period

5 months

First QC Date

January 12, 2010

Last Update Submit

January 12, 2010

Conditions

Seasonal Affective Disorder

Keywords

Seasonal affective disorderphototherapycircadian rhythmsblue enriched lightmelanopsinPrimary disease: Seasonal Affective Disorder, winter type

Outcome Measures

Primary Outcomes (1)

  • SIGH SAD depression observer rating

    days 1, 8, 15, 22

Secondary Outcomes (1)

  • selfrating of depressive mood

    once daily during 22 days

Study Arms (3)

Standard Light Treatment

ACTIVE COMPARATOR

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

Device: Original Energy Light,

Blue enriched Light treatment 20 min

EXPERIMENTAL

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

Device: Original Energy Light prototype

Blue enriched light treatment 30 min

EXPERIMENTAL

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

Device: Original Energy Light prototype

Interventions

Original Energy Light,DEVICE

9000 lux, 30 minutes in the morning

Also known as: Philips energy light HF 3308; 2 lamps PLL36W color 5000K
Standard Light Treatment
Original Energy Light prototypeDEVICE

9000 lux 20 minutes in the morning

Also known as: Philips energy light HF 3308; 2 lamps PLL36W color 17000K
Blue enriched Light treatment 20 min

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21911257DERIVED

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Y. Meesters, PhD

    Department of Psychiatry, University Medical Center Groningen, The Netherlands

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

October 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 13, 2010

Record last verified: 2005-10

Locations

NL(1)