Clinical Trials of Two Non-drug Treatments for Chronic Depression

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: August 11, 2000
Last updated: September 30, 2014
Last verified: March 2008
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 Intervention
Mood Disorders
Depressive Disorders
Chronic Depression
Device: Bright light box
Device: High-output negative ion generator
Device: Low-output negative ion generator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light and Negative Ion Treatment for Chronic Depression

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Depression scale score [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    change in score relative to baseline

Secondary Outcome Measures:
  • pineal melatonin onset tme [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    change in melatonin onset phase relative to baseline

Enrollment: 32
Study Start Date: April 2000
Study Completion Date: February 2004
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00006172

United States, Connecticut
Department of Psychology, Wesleyan University
Middletown, Connecticut, United States, 06459
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Study Director: Michael Terman NYS Psuchiatric Institute
  More Information

Additional Information:
Responsible Party: New York State Psychiatric Institute Identifier: NCT00006172     History of Changes
Other Study ID Numbers: #3554/R01 MH42931-02  R01MH042931-02 
Study First Received: August 11, 2000
Last Updated: September 30, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Antidepressive Agents
Circadian rhythms
Depressive Disorder
Mood disorders

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Pathologic Processes processed this record on May 26, 2016