Clinical Trials of Two Non-drug Treatments for Chronic Depression

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00006172
First received: August 11, 2000
Last updated: March 4, 2008
Last verified: March 2008
  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

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

Resource links provided by NLM:


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
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 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006172     History of Changes
Other Study ID Numbers: R01 MH42931-02, DSIR AT-SO
Study First Received: August 11, 2000
Last Updated: March 4, 2008
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.

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

ClinicalTrials.gov processed this record on September 30, 2014