NCT01149135

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
Last Updated

August 10, 2011

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

June 22, 2010

Last Update Submit

August 9, 2011

Conditions

Keywords

Seasonal Affective Disorderphototherapycircadian rhythmsblue enriched lightmelanopsinlow intensity

Outcome Measures

Primary Outcomes (1)

  • SIGH-SAD

    Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version

    weekly

Study Arms (2)

Standard light treatment

ACTIVE COMPARATOR

standard light treatment 5000K; 10 000 lux

Device: standard light treatment

blue enriched light

EXPERIMENTAL

Blue enriched light with a low intensity (750 lux)

Device: Blue enriched light with a low intensity

Interventions

30 minutes in the morning, 750 lux

Also known as: Blue enriched light treatment, Philips energy light HF 3309, 2 lamps PLL36 W 17000 K
blue enriched light

standard light treatment, 30 minutes, 10 000 lux

Also known as: Philips Energylight HF 3309, 2 lamps PLL36 W, color 5000K, 10 000 lux
Standard light treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

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

June 22, 2010

First Posted

June 23, 2010

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 10, 2011

Record last verified: 2008-10