Clinical Trials of Two Non-drug Treatments 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.
Device: Bright light box
Device: Negative ion generator
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Light and Negative Ion Treatment for Chronic Depression|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006172
|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|