Seasonal Affective DisorderNCT01048294
Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)
A study testing Original Energy Light, and Original Energy Light prototype in people with Seasonal Affective Disorder, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Original Energy Light, and Original Energy Light prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Psychiatry, University Medical Center Groningen
Groningen, 9700RB
About this study
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
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.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Original Energy Light,, Original Energy Light prototype
- Keywords
- Seasonal affective disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, Primary disease: Seasonal Affective Disorder, winter type
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original Energy Light,Device
Also called Philips energy light HF 3308; 2 lamps PLL36W color 5000K
9000 lux, 30 minutes in the morning
Original Energy Light prototypeDevice
Also called Philips energy light HF 3308; 2 lamps PLL36W color 17000K
9000 lux 20 minutes in the morning
Original Energy Light prototypeDevice
Also called Philips energy light HF 3308; 2 lamps PLL36W color 17000K
9000 lux 30 minutes in the morning
| Study group | Role | What they receive |
|---|---|---|
| Standard Light Treatment | Active comparator | 30 min of Standard bright light treatment (color 5000K) Receives: Device: Original Energy Light, |
| Blue enriched Light treatment 20 min | Experimental | 20 minutes of Blue enriched light treatment (color 17000K) Receives: Device: Original Energy Light prototype |
| Blue enriched light treatment 30 min | Experimental | 30 minutes of Blue enriched light treatment (color 17000K) Receives: Device: Original Energy Light prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIGH SAD depression observer rating
Measured: days 1, 8, 15, 22
Secondary outcomes (1)
selfrating of depressive mood
Measured: once daily during 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Y. Meesters, PhD, Study chair, Department of Psychiatry, University Medical Center Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048294
- Sponsor's protocol ID
- METc2005/160
- Status last verified
- Oct 2005
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21911257
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01048294
- Acronym / sponsor ID
- METc2005/160
- Conditions
- Seasonal Affective Disorder
- Keywords
- Seasonal affective disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, Primary disease: Seasonal Affective Disorder, winter type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Light Treatment | Active comparator | Device: Original Energy Light,30 min of Standard bright light treatment (color 5000K) |
| Blue enriched Light treatment 20 min | Experimental | Device: Original Energy Light prototype20 minutes of Blue enriched light treatment (color 17000K) |
| Blue enriched light treatment 30 min | Experimental | Device: Original Energy Light prototype30 minutes of Blue enriched light treatment (color 17000K) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Original Energy Light,Also: Philips energy light HF 3308; 2 lamps PLL36W color 5000K9000 lux, 30 minutes in the morning | Device | Standard Light Treatment |
| Original Energy Light prototypeAlso: Philips energy light HF 3308; 2 lamps PLL36W color 17000K9000 lux 20 minutes in the morning | Device | Blue enriched Light treatment 20 min |
| Original Energy Light prototypeAlso: Philips energy light HF 3308; 2 lamps PLL36W color 17000K9000 lux 30 minutes in the morning | Device | Blue enriched light treatment 30 min |
Primary outcome
SIGH SAD depression observer rating
Time frame: days 1, 8, 15, 22
1 secondary outcome
selfrating of depressive mood
Time frame: once daily during 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Derived from this study: PubMed 21911257Gordijn 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.
Related trials for Seasonal Affective Disorder
Not yet recruiting
Treating Seasonal Depression With Daylight
Depression
RecruitingObservational study
Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders
Major Depressive Episode
Not yet recruiting
Virtual Reality Digital Therapeutics for Seasonal Affective Disorder
Seasonal Affective Disorder (SAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Y. Meesters, PhD study chair
Department of Psychiatry, University Medical Center Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original Energy Light, and Original Energy Light prototype in people with Seasonal Affective Disorder, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIGH SAD depression observer rating (time frame: days 1, 8, 15, 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.