Mood DisordersNCT00006172
Clinical Trials of Two Non-drug Treatments for Chronic Depression
A study testing Bright light box, High-output negative ion generator and Low-output negative ion generator in people with Mood Disorders and Depressive Disorders, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorders, Depressive Disorders, Depression
- What is being tested?
- Bright light box, High-output negative ion generator and Low-output negative ion generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2000to Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depression
- Must be able to maintain a regular sleep schedule
Who cannot join
- Depression restricted to certain seasons of the year
- Presence of other psychiatric disorders
- Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
- Current use of recreational drugs or supplements that may affect mood
- Current medical illness or medication that may affect response to antidepressant treatment
- Long-distance travel while participating in the program
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Psychology, Wesleyan University
Middletown, Connecticut, 06459
Columbia Presbyterian Medical Center
New York, New York, 10032
About this study
Official title: Light and Negative Ion Treatment for Chronic Depression
This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.
Read the detailed description
Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.
Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.
- Conditions
- Mood Disorders, Depressive Disorders, Depression, Chronic Depression
- Being tested
- Bright light box, High-output negative ion generator, Low-output negative ion generator
- Keywords
- Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting, Mood disorders, Phototherapy.
- Medical subject headings
- Mood Disorders, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light boxDevice
60-min light therapy shortly after awakening
High-output negative ion generatorDevice
60-min high-density ion exposure shortly after awakening
Low-output negative ion generatorDevice
60-min low-density ion exposure shortly after awakening
| Study group | Role | What they receive |
|---|---|---|
| bright light box | Active comparator | 60 min light therapy shortly after awakening Receives: Device: Bright light box |
| high-output negative ion generator | Active comparator | 60 min high-density exposure shortly after awakening Receives: Device: High-output negative ion generator |
| low-output negative ion generator | Placebo comparator | 60 min low-density exposure shortly after awakening Receives: Device: Low-output negative ion generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression scale score
change in score relative to baseline
Measured: 5 weeks
Secondary outcomes (1)
pineal melatonin onset tme
change in melatonin onset phase relative to baseline
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2000 (estimated)
- Study startApr 2000
- Primary completionJul 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies 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
- 32 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, Study director, NYS Psuchiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006172
- Sponsor's protocol ID
- #3554/R01 MH42931-02
- Other IDs
- R01MH042931-02
- Status last verified
- Mar 2008
- First submitted
- 11 Aug 2000
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Terman 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 9783557Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
PubMed 9609674
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light and Negative Ion Treatment for Chronic Depression
- ClinicalTrials.gov ID
- NCT00006172
- Acronym / sponsor ID
- #3554/R01 MH42931-02
- Conditions
- Mood Disorders, Depressive Disorders, Depression, Chronic Depression
- Keywords
- Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2000
- Primary completion
- Jul 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 14 Aug 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.
This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.
Detailed description
Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.
Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bright light box | Active comparator | Device: Bright light box60 min light therapy shortly after awakening |
| high-output negative ion generator | Active comparator | Device: High-output negative ion generator60 min high-density exposure shortly after awakening |
| low-output negative ion generator | Placebo comparator | Device: Low-output negative ion generator60 min low-density exposure shortly after awakening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depression
- Must be able to maintain a regular sleep schedule
Key exclusion criteria (7 listed)
- Depression restricted to certain seasons of the year
- Presence of other psychiatric disorders
- Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
- Current use of recreational drugs or supplements that may affect mood
- Current medical illness or medication that may affect response to antidepressant treatment
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 box60-min light therapy shortly after awakening | Device | bright light box |
| High-output negative ion generator60-min high-density ion exposure shortly after awakening | Device | high-output negative ion generator |
| Low-output negative ion generator60-min low-density ion exposure shortly after awakening | Device | low-output negative ion generator |
Primary outcome
Depression scale score
Time frame: 5 weeks
change in score relative to baseline
1 secondary outcome
pineal melatonin onset tme
Time frame: 5 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 1 Oct 2014.
- 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.
- Background: PubMed 9609674Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
- Click here for a description of environmental therapiesLink provided by the sponsor.
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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.
Michael Terman study director
NYS Psuchiatric Institute
2 sites 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, High-output negative ion generator and Low-output negative ion generator in people with Mood Disorders and Depressive Disorders, run by New York State Psychiatric Institute at 2 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 2 inclusion and 7 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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: 5 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 NCT00006172, which also lists 2 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 1 Oct 2014.