Clinical Trials of Two Non-drug Treatments for Chronic Depression

New York State Psychiatric Institute

Status: Completed

Conditions: Depressive Disorders; Chronic Depression; Depression; Mood Disorders

Treatments: Device: High-output negative ion generator; Device: Bright light box; Device: Low-output negative ion generator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006172

R01MH042931-02 (U.S. NIH Grant/Contract)

#3554/R01 MH42931-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 3 patient groups, including a placebo group

bright light box

Active Comparator group

Description:

60 min light therapy shortly after awakening

Treatment:

Device: Bright light box

high-output negative ion generator

Active Comparator group

Description:

60 min high-density exposure shortly after awakening

Treatment:

Device: High-output negative ion generator

low-output negative ion generator

Placebo Comparator group

Description:

60 min low-density exposure shortly after awakening

Treatment:

Device: Low-output negative ion generator