Seasonal Affective DisorderNCT01149135
Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder
A study testing Blue enriched light with a low intensity and standard light treatment in people with Seasonal Affective Disorder, run by University Medical Center Groningen.
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. 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?
- Blue enriched light with a low intensity and standard light treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2009
- 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
- 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
Who cannot join
- 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
About this study
Official title: Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
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.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Blue enriched light with a low intensity, standard light treatment
- Keywords
- Seasonal Affective Disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, low intensity
- 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.
Blue enriched light with a low intensityDevice
Also called Blue enriched light treatment, Philips energy light HF 3309, 2 lamps PLL36 W 17000 K
30 minutes in the morning, 750 lux
standard light treatmentDevice
Also called Philips Energylight HF 3309, 2 lamps PLL36 W, color 5000K, 10 000 lux
standard light treatment, 30 minutes, 10 000 lux
| Study group | Role | What they receive |
|---|---|---|
| Standard light treatment | Active comparator | standard light treatment 5000K; 10 000 lux Receives: Device: standard light treatment |
| blue enriched light | Experimental | Blue enriched light with a low intensity (750 lux) Receives: Device: Blue enriched light with a low intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIGH-SAD
Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149135
- Sponsor's protocol ID
- METc 2008.184
- Status last verified
- Oct 2008
- First submitted
- 22 Jun 2010
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT01149135
- Acronym / sponsor ID
- METc 2008.184
- Conditions
- Seasonal Affective Disorder
- Keywords
- Seasonal Affective Disorder, phototherapy, circadian rhythms, blue enriched light, melanopsin, low intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard light treatment | Active comparator | Device: standard light treatmentstandard light treatment 5000K; 10 000 lux |
| blue enriched light | Experimental | Device: Blue enriched light with a low intensityBlue enriched light with a low intensity (750 lux) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Blue enriched light with a low intensityAlso: Blue enriched light treatment, Philips energy light HF 3309, 2 lamps PLL36 W 17000 K30 minutes in the morning, 750 lux | Device | blue enriched light |
| standard light treatmentAlso: Philips Energylight HF 3309, 2 lamps PLL36 W, color 5000K, 10 000 luxstandard light treatment, 30 minutes, 10 000 lux | Device | Standard light treatment |
Primary outcome
SIGH-SAD
Time frame: weekly
Structured Interview Guide of the Hamilton Depression Scale, seasonal affective disorder version
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 10 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blue enriched light with a low intensity and standard light treatment in people with Seasonal Affective Disorder, run by University Medical Center Groningen.
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 4 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2011.