Clinical Trials of Two Non-drug Treatments for Chronic Depression

Study Overview
=================
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.

Official Title
-----------------
Light and Negative Ion Treatment for Chronic Depression

Conditions
-----------------
Mood Disorders, Depressive Disorders, Depression, Chronic Depression

Intervention / Treatment
-----------------
* Device: Bright light box
* Device: High-output negative ion generator
* Device: Low-output negative ion generator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bright light box<br>60 min light therapy shortly after awakening | Device: Bright light box<br>* 60-min light therapy shortly after awakening<br>|
| Active Comparator: high-output negative ion generator<br>60 min high-density exposure shortly after awakening | Device: High-output negative ion generator<br>* 60-min high-density ion exposure shortly after awakening<br>|
| Placebo Comparator: low-output negative ion generator<br>60 min low-density exposure shortly after awakening | Device: Low-output negative ion generator<br>* 60-min low-density ion exposure shortly after awakening<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scale score | change in score relative to baseline | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pineal melatonin onset tme | change in melatonin onset phase relative to baseline | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting, Mood disorders, Phototherapy.