Seasonal Affective DisorderPhase 2/3NCT00809523
A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
A Phase 2/3 study testing Negative Ion Generator and Light-emitting Photodiode light treatment device in people with Seasonal Affective Disorder, run by Yale University at 8 sites in 3 countries.
Trial summary
This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this… 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?
- Negative Ion Generator and Light-emitting Photodiode light treatment device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2008to Apr 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Seasonal Affective Disorder
- Age 18 to 65
Who cannot join
- Psychotropic medication treatment
- History of light treatment for SAD
- History of mania or psychosis
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Canada4 sites
St. John Regional Hospital
Saint John, New Brunswick, E2l 4L2
CAMH/University of Toronto
Toronto, Ontario, M5T 1R8
Sleep and Alertness Inc
Toronto, Ontario
University of British Columbia
Vancouver, British Columbia, V6T 2A1
United States3 sites
McLean Hospital/Harvard
Belmont, Massachusetts, 02478
Yale University School of Medicine
New Haven, Connecticut, 06504
Capital Clinical Research Associates
Rockville, Maryland, 20852
About this study
Official title: A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.
Read the detailed description
This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Negative Ion Generator, Light-emitting Photodiode light treatment device
- Keywords
- SAD, winter depression
- 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.
Negative Ion GeneratorDevice
Equivalent exposure to inactivated Negative Ion Generator
Light-emitting Photodiode light treatment deviceDevice
Light-emitting Photodiode light treatment device, used for 30 min before 8 am
| Study group | Role | What they receive |
|---|---|---|
| Inactivated negative ion generator | Experimental | Equivalent exposure to inactivated Negative Ion Generator Receives: Device: Negative Ion Generator |
| LED light treatment device | Experimental | Light-emitting photodiode light treatment device, used for 30 min before 8 am Receives: Device: Light-emitting Photodiode light treatment device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change SIGH SAD Depression Rating
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.
Calculated: SIGH SAD score at trial end - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization
Measured: 4 weeks
Secondary outcomes (2)
SIGH SAD Depression Rating
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.
Measured: Weekly
Clinical Global Impression of Severity
The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.
Measured: Randomization and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Litebook Company Ltd., University of British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Harvard University, University of Toronto, Clinical Associates Research, Maryland, Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Paul Desan, MD, PhD, Principal investigator, Yale UniversityRaymond Lam, MD, Principal investigator, University of British Columbia, Vancouver, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809523
- Sponsor's protocol ID
- 0810004322
- Status last verified
- Jan 2013
- First submitted
- 16 Dec 2008
- Last updated
- 6 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)
- ClinicalTrials.gov ID
- NCT00809523
- Acronym / sponsor ID
- 0810004322
- Conditions
- Seasonal Affective Disorder
- Keywords
- SAD, winter depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The Litebook Company Ltd., University of British Columbia, McGill University Health Centre/Research Institute of the McGill University Health Centre, Harvard University, University of Toronto, Clinical Associates Research, Maryland, Dalhousie University
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 6 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.
Detailed description
This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactivated negative ion generator | Experimental | Device: Negative Ion GeneratorEquivalent exposure to inactivated Negative Ion Generator |
| LED light treatment device | Experimental | Device: Light-emitting Photodiode light treatment deviceLight-emitting photodiode light treatment device, used for 30 min before 8 am |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Seasonal Affective Disorder
- Age 18 to 65
Key exclusion criteria (3 listed)
- Psychotropic medication treatment
- History of light treatment for SAD
- History of mania or psychosis
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 |
|---|---|---|
| Negative Ion GeneratorEquivalent exposure to inactivated Negative Ion Generator | Device | Inactivated negative ion generator |
| Light-emitting Photodiode light treatment deviceLight-emitting Photodiode light treatment device, used for 30 min before 8 am | Device | LED light treatment device |
Primary outcome
Percentage Change SIGH SAD Depression Rating
Time frame: 4 weeks
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression. Calculated: SIGH SAD score at trial end - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization
2 secondary outcomes
SIGH SAD Depression Rating
Time frame: Weekly
Clinical Global Impression of Severity
Time frame: Randomization and at 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Seasonal Affective Disorder
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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.
Paul Desan, MD, PhD principal investigator
Yale University
Raymond Lam, MD principal investigator
University of British Columbia, Vancouver, Canada
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Negative Ion Generator and Light-emitting Photodiode light treatment device in people with Seasonal Affective Disorder, run by Yale University at 8 sites in 3 countries.
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 2 inclusion and 3 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 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United States, 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change SIGH SAD Depression Rating (time frame: 4 weeks). 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 6 Mar 2013.