Clinical Trials of Two Non-drug Treatments for Chronic Depression

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00006172

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mood Disorders Depressive Disorders Depression Chronic Depression	Device: Bright light box Device: High-output negative ion generator Device: Low-output negative ion generator	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Light and Negative Ion Treatment for Chronic Depression

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jul 1, 2003

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: bright light box

60 min light therapy shortly after awakening

Device: Bright light box

60-min light therapy shortly after awakening

Active Comparator: high-output negative ion generator

60 min high-density exposure shortly after awakening

Device: High-output negative ion generator

60-min high-density ion exposure shortly after awakening

Placebo Comparator: low-output negative ion generator

60 min low-density exposure shortly after awakening

Device: Low-output negative ion generator

60-min low-density ion exposure shortly after awakening

Outcome Measures

Primary Outcome Measures

Depression scale score [5 weeks]
change in score relative to baseline

Secondary Outcome Measures

pineal melatonin onset tme [5 weeks]
change in melatonin onset phase relative to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychology, Wesleyan University	Middletown	Connecticut	United States	06459
2	Columbia Presbyterian Medical Center	New York	New York	United States	10032