Seasonal Affective DisorderNCT00006517
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
A study testing bright light box, dawn simulator and high-output negative ion generator in people with Seasonal Affective Disorder and Mood Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter. The treatments are self-administered at home by the patient, with close clinical supervision. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Seasonal Affective Disorder, Mood Disorders, Depression
- What is being tested?
- bright light box, dawn simulator and high-output negative ion generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Apr 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring
- Able to maintain a regular sleep schedule
Who cannot join
- Presence of psychiatric disorders other than major depression or bipolar depression
- Current use of antidepressant or recreational drugs, or psychotropic medication or supplements that may affect mood
- Current medical illness or medication that might interfere with response to treatment
- Long-distance travel during the program
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Presbyterian Medical Center
New York, New York, 10032
About this study
Official title: Light and Ion Therapy for Seasonal Affective Disorder
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter. The treatments are self-administered at home by the patient, with close clinical supervision. Our trials use specially designed devices that replenish two different environmental elements, naturally occurring light and negative ions in the air. Both factors may be reduced in winter, bringing on depression.
Read the detailed description
The treatments we are investigating include bright light therapy upon awakening, and two contrasting treatments during the final hours of sleep: negative air ionization (provided at two levels) and dawn simulation (also at two levels), both switched on by a silent electronic timer or microprocessor. We hypothesize that the reduced outdoor light availability in winter, as well as reduced concentration of negative ions in the air circulation are both factors that contribute to depression. By supplementing the indoor environment with either ions or light, we are aiming to recreate summer-like conditions that are therapeutic. Our past studies have shown all three methods to have antidepressant effects in patients with seasonal affective disorder (SAD). Unlike light therapy, negative air ionization is imperceptible (you cannot sense when the ionizer is active).
Applications to the program are accepted and reviewed throughout the year. Screening interviews for entry into the program are scheduled between August and February. Patients and researchers both benefit most when applications are received by the start of the individual's "problem season," because this leaves maximum time to explore alternate treatments. Candidates undergo a two-hour personal interview at Columbia-Presbyterian Medical Center that ascertains whether they meet inclusion criteria. At a second two-hour visit we provide a standard medical examination including blood tests, urinalysis and EKG, all without cost. As an alternative, physicals may be performed by one's personal physician. Once the study is underway, there are about five additional one-hour appointments for clinical evaluations, flexibly scheduled during the business day, usually about 10 days apart.
We provide the treatment apparatus on loan. All treatments are scheduled in the morning around the time of awakening. The bedroom treatments (negative ions or dawn simulation) end by the time of awakening. The bright light treatment takes place for half an hour after waking up. Initially, patients are randomly assigned to one of the treatment groups. The treatment must be taken consistently for three weeks at the same time every day, after which it is temporarily suspended to determine whether symptoms return. Given sufficient time within the winter season, patients then have the opportunity to try one of the alternate treatments to determine which works best for them. This provides an informed, confident basis for a treatment plan for subsequent years.
As part of the protocol, patients provide saliva samples on two evenings, which are used to test for the level of melatonin, a hormone that becomes active at night. Results reveal whether a person's internal circadian rhythm is early, late or normal, information that can be used to guide the timing of future treatment. This constitutes a distinct benefit for research participants, since such a diagnostic test is not yet available in medical practice.
- Conditions
- Seasonal Affective Disorder, Mood Disorders, Depression
- Being tested
- bright light box, dawn simulator, high-output negative ion generator, low-output negative ion generator, dawn light pulse
- Keywords
- Seasonal Affective Disorder (SAD), Winter Depression, Mood disorders, Bipolar I and II disorders, Major Depressive Disorder, Recurrent, Light therapy, Phototherapy, Dawn Simulation therapy, Negative air ionization therapy, Chronobiology, Biological rhythms
- Medical subject headings
- Seasonal Affective Disorder, Mood Disorders, Depression, Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bright light boxDevice
10,000 lux bright light therapy
dawn simulatorDevice
gradual rise in bedroom illumination prior to wake-up
high-output negative ion generatorDevice
automated air ion delivery in bedroom prior to wake-up
low-output negative ion generatorDevice
automated air ion delivery in bedroom prior to wake-up
dawn light pulseDevice
rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
| Study group | Role | What they receive |
|---|---|---|
| bright light box | Active comparator | 30 min exposure shortly after wake-up Receives: Device: bright light box |
| high-output negative ion generator | Active comparator | 90 min exposure prior to wake-up Receives: Device: high-output negative ion generator |
| low-output negative ion generator | Placebo comparator | 90 min exposure prior to wake-up Receives: Device: low-output negative ion generator |
| dawn simulator | Active comparator | naturalistic incremental light exposure 90 min prior to wake-up Receives: Device: dawn simulator |
| dawn light pulse | Experimental | rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal Receives: Device: dawn light pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression scale score
reduction from depressed baseline
Measured: 3 weeks
Secondary outcomes (1)
time of pineal melatonin onset
change from depressed baseline
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2000 (estimated)
- Study startSep 1998
- Primary completionJun 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael Terman, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006517
- Sponsor's protocol ID
- #3032/R01 MH42931-01
- Other IDs
- R01MH042931-01
- Status last verified
- Nov 2005
- First submitted
- 22 Nov 2000
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Caldwell M. Mind over time. Discover Magazine, July 1999;50-59. <http://www.discover.com/july_99/featmind.html>
Terman M, Lewy AJ, Dijk DJ, Boulos Z, Eastman CI, Campbell SS. Light treatment for sleep disorders: consensus report. IV. Sleep phase and duration disturbances. J Biol Rhythms. 1995 Jun;10(2):135-47. doi: 10.1177/074873049501000206.
PubMed 7632987Terman M, Terman JS, Ross DC. A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):875-82. doi: 10.1001/archpsyc.55.10.875.
PubMed 9783557Terman M; Terman JS; Williams JBW. Seasonal affective disorder and its treatments. J Pract Psychiatry Behav Health 1998;5:387-303. <http://www.practicalpsychiatry.com>
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light and Ion Therapy for Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT00006517
- Acronym / sponsor ID
- #3032/R01 MH42931-01
- Conditions
- Seasonal Affective Disorder, Mood Disorders, Depression
- Keywords
- Seasonal Affective Disorder (SAD), Winter Depression, Mood disorders, Bipolar I and II disorders, Major Depressive Disorder, Recurrent, Light therapy, Phototherapy, Dawn Simulation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1998
- Primary completion
- Jun 2003 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 23 Nov 2000 (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.
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter. The treatments are self-administered at home by the patient, with close clinical supervision. Our trials use specially designed devices that replenish two different environmental elements, naturally occurring light and negative ions in the air. Both factors may be reduced in winter, bringing on depression.
Detailed description
The treatments we are investigating include bright light therapy upon awakening, and two contrasting treatments during the final hours of sleep: negative air ionization (provided at two levels) and dawn simulation (also at two levels), both switched on by a silent electronic timer or microprocessor. We hypothesize that the reduced outdoor light availability in winter, as well as reduced concentration of negative ions in the air circulation are both factors that contribute to depression. By supplementing the indoor environment with either ions or light, we are aiming to recreate summer-like conditions that are therapeutic. Our past studies have shown all three methods to have antidepressant effects in patients with seasonal affective disorder (SAD). Unlike light therapy, negative air ionization is imperceptible (you cannot sense when the ionizer is active).
Applications to the program are accepted and reviewed throughout the year. Screening interviews for entry into the program are scheduled between August and February. Patients and researchers both benefit most when applications are received by the start of the individual's "problem season," because this leaves maximum time to explore alternate treatments. Candidates undergo a two-hour personal interview at Columbia-Presbyterian Medical Center that ascertains whether they meet inclusion criteria. At a second two-hour visit we provide a standard medical examination including blood tests, urinalysis and EKG, all without cost. As an alternative, physicals may be performed by one's personal physician. Once the study is underway, there are about five additional one-hour appointments for clinical evaluations, flexibly scheduled during the business day, usually about 10 days apart.
We provide the treatment apparatus on loan. All treatments are scheduled in the morning around the time of awakening. The bedroom treatments (negative ions or dawn simulation) end by the time of awakening. The bright light treatment takes place for half an hour after waking up. Initially, patients are randomly assigned to one of the treatment groups. The treatment must be taken consistently for three weeks at the same time every day, after which it is temporarily suspended to determine whether symptoms return. Given sufficient time within the winter season, patients then have the opportunity to try one of the alternate treatments to determine which works best for them. This provides an informed, confident basis for a treatment plan for subsequent years.
As part of the protocol, patients provide saliva samples on two evenings, which are used to test for the level of melatonin, a hormone that becomes active at night. Results reveal whether a person's internal circadian rhythm is early, late or normal, information that can be used to guide the timing of future treatment. This constitutes a distinct benefit for research participants, since such a diagnostic test is not yet available in medical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| bright light box | Active comparator | Device: bright light box30 min exposure shortly after wake-up |
| high-output negative ion generator | Active comparator | Device: high-output negative ion generator90 min exposure prior to wake-up |
| low-output negative ion generator | Placebo comparator | Device: low-output negative ion generator90 min exposure prior to wake-up |
| dawn simulator | Active comparator | Device: dawn simulatornaturalistic incremental light exposure 90 min prior to wake-up |
| dawn light pulse | Experimental | Device: dawn light pulserectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring
- Able to maintain a regular sleep schedule
Key exclusion criteria (4 listed)
- Presence of psychiatric disorders other than major depression or bipolar depression
- Current use of antidepressant or recreational drugs, or psychotropic medication or supplements that may affect mood
- Current medical illness or medication that might interfere with response to treatment
- Long-distance travel during the program
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 |
|---|---|---|
| bright light box10,000 lux bright light therapy | Device | bright light box |
| dawn simulatorgradual rise in bedroom illumination prior to wake-up | Device | dawn simulator |
| high-output negative ion generatorautomated air ion delivery in bedroom prior to wake-up | Device | high-output negative ion generator |
| low-output negative ion generatorautomated air ion delivery in bedroom prior to wake-up | Device | low-output negative ion generator |
| dawn light pulserectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up | Device | dawn light pulse |
Primary outcome
Depression scale score
Time frame: 3 weeks
reduction from depressed baseline
1 secondary outcome
time of pineal melatonin onset
Time frame: 3 weeks
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 3 Jun 2015.
- BackgroundCaldwell M. Mind over time. Discover Magazine, July 1999;50-59. <http://www.discover.com/july_99/featmind.html>
- Background: PubMed 7632987Terman M, Lewy AJ, Dijk DJ, Boulos Z, Eastman CI, Campbell SS. Light treatment for sleep disorders: consensus report. IV. Sleep phase and duration disturbances. J Biol Rhythms. 1995 Jun;10(2):135-47. doi: 10.1177/074873049501000206.
- Background: PubMed 9783557Terman M, Terman JS, Ross DC. A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):875-82. doi: 10.1001/archpsyc.55.10.875.
- BackgroundTerman M; Terman JS; Williams JBW. Seasonal affective disorder and its treatments. J Pract Psychiatry Behav Health 1998;5:387-303. <http://www.practicalpsychiatry.com>
- Click here for more information about our study. Also, you can print out a confidential preliminary application to mail or fax to our center for quick review.Link provided by the sponsor.
- Click here for information about SAD and its treatments, presented by the Center for Environmental Therapeutics, a 501(c)(3) nonprofit professional agency.Link provided by the sponsor.
- Background reference: Click hear to read the abstract of Dr. Terman's article, "Seasonal Affective Disorder and its Treatments," in the Journal of Practical Psychiatry and Behavioral Health (at the site, click on "Contents," September 1998).Link provided by the sponsor.
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.
Michael Terman principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bright light box, dawn simulator and high-output negative ion generator in people with Seasonal Affective Disorder and Mood Disorders, run by New York State Psychiatric Institute at 1 site 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 2 inclusion and 4 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 3 Jun 2015. 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 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. 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?
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?
Depression scale score (time frame: 3 weeks). 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 NCT00006517, which also lists 4 linked publications.
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 3 Jun 2015.