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Clinical Trials of Two Non-Drug Treatments for Chronic Depression

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00006172
  Purpose

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
Depression
Chronic Depression
Nonseasonal Depression
Device: Bright light box
Device: Negative ion generator

MedlinePlus related topics:   Depression   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:   Light and Negative Ion Treatment for Chronic Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   100
Study Start Date:   April 2000
Estimated Study Completion Date:   June 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006172

Locations
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

Investigators
Investigator:     Michael Terman     Columbia University    
  More Information


Click here for study information and application  This link exits the ClinicalTrials.gov site
 
Click here for a description of environmental therapies  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   R01 MH42931-02, DSIR AT-SO
First Received:   August 11, 2000
Last Updated:   March 4, 2008
ClinicalTrials.gov Identifier:   NCT00006172
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antidepressive Agents  
Chronobiology  
Chronotherapy  
Circadian rhythms  
Depressive Disorder  
Ions
Light
Lighting
Mood disorders
Phototherapy.

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on November 20, 2008




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