Clinical Trials of Two Non-drug Treatments for Chronic Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00006172
First received: August 11, 2000
Last updated: September 30, 2014
Last verified: March 2008

August 11, 2000
September 30, 2014
April 2000
July 2003   (final data collection date for primary outcome measure)
Depression scale score [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
change in score relative to baseline
Not Provided
Complete list of historical versions of study NCT00006172 on ClinicalTrials.gov Archive Site
pineal melatonin onset tme [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
change in melatonin onset phase relative to baseline
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Mood Disorders
  • Depressive Disorders
  • Depression
  • Chronic Depression
  • Device: Bright light box
    60-min light therapy shortly after awakening
  • Device: High-output negative ion generator
    60-min high-density ion exposure shortly after awakening
  • Device: Low-output negative ion generator
    60-min low-density ion exposure shortly after awakening
  • Active Comparator: bright light box
    60 min light therapy shortly after awakening
    Intervention: Device: Bright light box
  • Active Comparator: high-output negative ion generator
    60 min high-density exposure shortly after awakening
    Intervention: Device: High-output negative ion generator
  • Placebo Comparator: low-output negative ion generator
    60 min low-density exposure shortly after awakening
    Intervention: Device: Low-output negative ion generator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2004
July 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006172
#3554/R01 MH42931-02, R01MH042931-02
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Study Director: Michael Terman NYS Psuchiatric Institute
New York State Psychiatric Institute
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP