Clinical Trials of Two Non-drug Treatments for Chronic Depression
NCT ID: NCT00006172
Last Updated: 2014-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2000-04-30
2004-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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bright light box
60 min light therapy shortly after awakening
Bright light box
60-min light therapy shortly after awakening
high-output negative ion generator
60 min high-density exposure shortly after awakening
High-output negative ion generator
60-min high-density ion exposure shortly after awakening
low-output negative ion generator
60 min low-density exposure shortly after awakening
Low-output negative ion generator
60-min low-density ion exposure shortly after awakening
Interventions
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Bright light box
60-min light therapy shortly after awakening
High-output negative ion generator
60-min high-density ion exposure shortly after awakening
Low-output negative ion generator
60-min low-density ion exposure shortly after awakening
Eligibility Criteria
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Inclusion Criteria
* Must be able to maintain a regular sleep schedule
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Michael Terman
Role: STUDY_DIRECTOR
NYS Psuchiatric Institute
Locations
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Department of Psychology, Wesleyan University
Middletown, Connecticut, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Countries
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References
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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.
Kripke 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.
Related Links
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Click here for a description of environmental therapies
Other Identifiers
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#3554/R01 MH42931-02
Identifier Type: -
Identifier Source: org_study_id
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