Clinical Trials of Two Non-drug Treatments for Chronic Depression

Light and Negative Ion Treatment 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.

Study Overview

• Status: Completed
• Conditions: Depression; Mood Disorders; Depressive Disorders; Chronic Depression
• Intervention / Treatment: Device: Bright light box; Device: High-output negative ion generator; Device: Low-output negative ion generator

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Middletown, Connecticut, United States, 06459
      • Department of Psychology, Wesleyan University
  • New York
    • New York, New York, United States, 10032
      • Columbia Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Study Director: Michael Terman, NYS Psuchiatric Institute

Publications and helpful links

General Publications

• Terman M, Terman JS, Ross DC. A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):875-82. doi: 10.1001/archpsyc.55.10.875.
• Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.

Helpful Links

• Click here for a description of environmental therapies

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: August 11, 2000
• First Submitted That Met QC Criteria: August 11, 2000
• First Posted (Estimate): August 14, 2000

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Depressive Disorder; Antidepressive Agents; Light; Circadian rhythms; Chronotherapy; Mood disorders; Chronobiology; Phototherapy.; Ions; Lighting
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Depression; Depressive Disorder; Disease; Mood Disorders
• Other Study ID Numbers: #3554/R01 MH42931-02; R01MH042931-02 (U.S. NIH Grant/Contract)