Seasonal Affective DisorderNCT00139997
Environmental Treatment for Seasonal Affective Disorder (SAD)
A study testing Litebook treatment devices and Inactivated negative ion generator in people with Seasonal Affective Disorder, run by Yale University at 5 sites in 3 countries.
Trial summary
The purpose is to study treatments of Seasonal Affective Disorder (SAD). 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?
- Litebook treatment devices and Inactivated negative ion generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2002to Aug 2005
- Phase
- Interventional
- 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
- Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.
Who cannot join
- Significant suicidal risk
- Serious medical illness
- Pregnancy
- Other DSM-IV diagnoses
- Taking mood altering medication
- May not travel to a sunny destination during study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Canada3 sites
Douglas Hospital Research Centre
Montreal, Quebec, H4H 1R3
Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
Ottawa, Ontario, K1Z 7K4
University of British Columbia
Vancouver, British Columbia, V6T 2A1
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06504
About this study
Official title: A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder
The purpose is to study treatments of Seasonal Affective Disorder (SAD).
Read the detailed description
This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.
This trial has now been completed.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Litebook treatment devices, Inactivated negative ion generator
- Keywords
- Major Depression, Seasonal Affective Disorder (SAD)
- Medical subject headings
- Seasonal Affective Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Litebook treatment devicesDevice
Litebook LED phototherapy device used for 30 min before 8 am
Inactivated negative ion generatorDevice
Equivalent exposure to inactivated negative ion generator
| Study group | Role | What they receive |
|---|---|---|
| LED phototherapy device | Experimental | Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am Receives: Device: Litebook treatment devices |
| Inactivated Negative Ion Generator | Placebo comparator | Equivalent exposure to inactivated negative ion generator Receives: Device: Inactivated negative ion generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
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 x 100 / SIGH SAD score at randomization
Measured: Week 4
Secondary outcomes (1)
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, 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 following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJan 2002
- Primary completionAug 2005
- Study completionAug 2005
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.
- 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, University of British Columbia, Royal Ottawa Mental Health Centre, Douglas Hospital Research Centre
- Responsible party
- Sponsor
- Investigators
- Paul H. Desan, PhD, MD, Principal investigator, Yale New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139997
- Sponsor's protocol ID
- 22,777
- Other IDs
- 22,777
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2005
- Last updated
- 6 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
PubMed 17683643
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
- ClinicalTrials.gov ID
- NCT00139997
- Acronym / sponsor ID
- 22,777
- Conditions
- Seasonal Affective Disorder
- Keywords
- Major Depression, Seasonal Affective Disorder (SAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, University of British Columbia, Royal Ottawa Mental Health Centre, Douglas Hospital Research Centre
- Study start
- Jan 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 31 Aug 2005 (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.
The purpose is to study treatments of Seasonal Affective Disorder (SAD).
Detailed description
This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.
This trial has now been completed.
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 |
|---|---|---|
| LED phototherapy device | Experimental | Device: Litebook treatment devicesLitebook treatment devices: LED phototherapy device, used for 30 min before 8 am |
| Inactivated Negative Ion Generator | Placebo comparator | Device: Inactivated negative ion generatorEquivalent exposure to inactivated negative ion generator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.
Key exclusion criteria (6 listed)
- Significant suicidal risk
- Serious medical illness
- Pregnancy
- Other DSM-IV diagnoses
- Taking mood altering medication
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 |
|---|---|---|
| Litebook treatment devicesLitebook LED phototherapy device used for 30 min before 8 am | Device | LED phototherapy device |
| Inactivated negative ion generatorEquivalent exposure to inactivated negative ion generator | Device | Inactivated Negative Ion Generator |
Primary outcome
Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Time frame: Week 4
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 x 100 / SIGH SAD score at randomization
1 secondary outcome
SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version
Time frame: Weekly following randomization
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.
- Results publication: PubMed 17683643Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
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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 H. Desan, PhD, MD principal investigator
Yale New Haven Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Litebook treatment devices and Inactivated negative ion generator in people with Seasonal Affective Disorder, run by Yale University at 5 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 1 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 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 5 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. Some participants in this study may receive a placebo. 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?
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 SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version (time frame: Week 4). 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 NCT00139997, 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 6 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.