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Clinical Trials of Two Non-drug Treatments for Chronic Depression

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ClinicalTrials.gov Identifier: NCT00006172
Recruitment Status : Completed
First Posted : August 14, 2000
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):

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
Mood Disorders Depressive Disorders Depression Chronic Depression 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 Design

Study Type : Interventional  (Clinical Trial)
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 : April 2000
Primary Completion Date : July 2003
Study Completion Date : February 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

Outcome Measures

Primary Outcome Measures :
  1. Depression scale score [ Time Frame: 5 weeks ]
    change in score relative to baseline

Secondary Outcome Measures :
  1. pineal melatonin onset tme [ Time Frame: 5 weeks ]
    change in melatonin onset phase relative to baseline

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00006172     History of Changes
Other Study ID Numbers: #3554/R01 MH42931-02
R01MH042931-02 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2000    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: March 2008

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

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders