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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00006172 |
Purpose
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.
| Condition | Intervention |
|
Mood Disorders Depressive Disorders Depression Chronic Depression Nonseasonal Depression |
Device: Bright light box Device: Negative ion generator |
| MedlinePlus related topics: | Depression |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Light and Negative Ion Treatment for Chronic Depression |
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | June 2005 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |||||
| Department of Psychology, Wesleyan University | |||||
| Middletown, Connecticut, United States, 06459 | |||||
| United States, New York | |||||
| Columbia Presbyterian Medical Center | |||||
| New York, New York, United States, 10032 | |||||
| Investigator: | Michael Terman | Columbia University |
More Information
Click here for study information and application 
  |
Click here for a description of environmental therapies 
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| Study ID Numbers: | R01 MH42931-02, DSIR AT-SO |
| First Received: | August 11, 2000 |
| Last Updated: | March 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006172 |
| Health Authority: | United States: Federal Government |
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