Seasonal Affective DisorderSADNCT01462305
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
A study testing goLITE in people with Seasonal Affective Disorder, run by Philips Respironics at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- goLITE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jan 2012to 2 Apr 2012
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females, ages 21-64
- Able and willing to provide written informed consent
- History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Associated, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 2007)
- Bipolar I excluded for this study
- SIGH-ADS score of ≥20
- Use of the light device as instructed by the study clinician for at least 6 out of 7 days for the first two weeks of therapy and at least 5 out of 7 days for the remaining four weeks of therapy.
Who cannot join
- Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
- Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator.
- Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test
- History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
- History or current diagnosis of Bipolar I Disorder
- Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect
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- History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism)
- History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria
- Positive urine drug screen at the Physical Screening
- Active suicidal or homicidal ideation or plan, as determined by the investigator
- Global Assessment of Functioning (GAF) <51 (see Appendix B)
- Use of light therapy treatment within the previous 6 months or any history of goLITE use
- Pregnant or lactating (will confirm absence of pregnancy with a urine or serum pregnancy test in females of childbearing potential during the Physical Screening. Additional pregnancy tests may be performed as per individual site requirements). Females of child-bearing potential must agree to use some form of birth control throughout the course
- Current use or use within 2 months of antidepressants or mood stabilizing medications, even if taken for a non-psychiatric indication
- Currently working night shift or rotating shift or other habitual alteration of the sleep/wake cycle
- Planned travel outside of the state in which the trial is being conducted
- Current use or use within the previous 1 month of photosensitizing medications (amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin) or remedies (St. John's wort, melatonin)
- History of eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
- Ishihara score of <10 on the Ishihara Test for Color Deficiency
- Use of medications, such as tetracycline or oral isoretinoin (Accutane), that would affect the safety of light exposure treatment or that causes complaints of eyestrain or abnormal tearing with computer use of up to 30 minutes at a time
Trial locations and contacts
4 sites in 1 country.
United States4 sites
McLean Hospital
Belmont, Massachusetts, 02478
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Community Research Management Associates
Cincinnati, Ohio, 45227
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.
Read the detailed description
Participants will be randomly assigned to receive either a 467nm light or a 580nm light. Participants will use the light every day for six weeks for 30 minutes. Multiple assessments and questionnaires will be given weekly to assess the efficacy of the treatment.
- Conditions
- Seasonal Affective Disorder
- Being tested
- goLITE, Control
- Keywords
- SAD, Seasonal Affective Disorder, Winter Blues, Seasonal 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.
goLITEDevice
Also called Light device, Blue Light
goLITE at 30 minutes per day, within 30 minutes of waking in the morning
ControlDevice
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| goLITE | Experimental | light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks Receives: Device: goLITE |
| Control | Active comparator | light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIGH-ADS Score
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment.
The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
Measured: 6 weeks
Secondary outcomes (2)
SIGH-ADS Score (Week 1 Thru 5)
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized weekly at in person visits or over the phone.
The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome and the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
Measured: weekly, from Week 1 through week 5
Q-LES-Q-SF
The Q-LES-Q-SF (Quality of life enjoyment and satisfaction questionnaire short form) is a 16 question questionnaire that is enables investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning.
Responses to questions range from 1 to 5, 1 being very poor and 5 being very good. Scores range from 16 to 80, the higher score the higher the participants enjoyment and satisfaction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study start6 Jan 2012
- Primary completion2 Apr 2012
- Study completion2 Apr 2012
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.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janis Anderson, PhD, Principal investigator, Brigham and Women's HospitalRobert Auger, MD, Principal investigator, Mayo ClinicScott Crow, MD, Principal investigator, University of MinnesotaCarol Glod, PhD, Principal investigator, Mclean HospitalAlfredo Rivera, MD, Principal investigator, Community Research Management Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462305
- Sponsor's protocol ID
- CL-1033-SADGO-MS
- Acronym
- SAD
- Status last verified
- Jan 2019
- First submitted
- 27 Oct 2011
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT01462305
- Acronym / sponsor ID
- SAD / CL-1033-SADGO-MS
- Conditions
- Seasonal Affective Disorder
- Keywords
- SAD, Seasonal Affective Disorder, Winter Blues, Seasonal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2012 (actual)
- Primary completion
- 2 Apr 2012 (actual)
- Study completion
- 2 Apr 2012 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.
Detailed description
Participants will be randomly assigned to receive either a 467nm light or a 580nm light. Participants will use the light every day for six weeks for 30 minutes. Multiple assessments and questionnaires will be given weekly to assess the efficacy of the treatment.
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 |
|---|---|---|
| goLITE | Experimental | Device: goLITElight therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks |
| Control | Active comparator | Device: Controllight therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females, ages 21-64
- Able and willing to provide written informed consent
- History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Associated, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 2007)
- Bipolar I excluded for this study
- SIGH-ADS score of ≥20
Key exclusion criteria (20 listed)
- Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
- Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator.
- Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test
- History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
- History or current diagnosis of Bipolar I Disorder
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 |
|---|---|---|
| goLITEAlso: Light device, Blue LightgoLITE at 30 minutes per day, within 30 minutes of waking in the morning | Device | goLITE |
| Controllight therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks | Device | Control |
Primary outcome
SIGH-ADS Score
Time frame: 6 weeks
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
2 secondary outcomes
SIGH-ADS Score (Week 1 Thru 5)
Time frame: weekly, from Week 1 through week 5
Q-LES-Q-SF
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janis Anderson, PhD principal investigator
Brigham and Women's Hospital
Robert Auger, MD principal investigator
Mayo Clinic
Scott Crow, MD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goLITE in people with Seasonal Affective Disorder, run by Philips Respironics at 4 sites in United States.
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 6 inclusion and 20 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2019). 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?
SIGH-ADS Score (time frame: 6 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 30 Jan 2019.