Chronic Depression, Depression, Depressive Disorders, Mood Disorders
Conditions
Keywords
Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting, Mood disorders, Phototherapy.
Brief 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.
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.
Interventions
DEVICEBright light box
60-min light therapy shortly after awakening
60-min high-density ion exposure shortly after awakening
60-min low-density ion exposure shortly after awakening
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of major depression * Must be able to maintain a regular sleep schedule
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression scale score | 5 weeks | change in score relative to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pineal melatonin onset tme | 5 weeks | change in melatonin onset phase relative to baseline |
Countries
United States
Outcome results
None listed