Clinical Trial: 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)

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 Treatment or Intervention
Mood Disorders
Depressive Disorders
Depression
Chronic depression
Nonseasonal depression
 Device: Bright light box
 Device: Negative ion generator

MedlinePlus related topics:  Bipolar Disorder;   Depression;   Mental Health

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: 

Expected Total Enrollment:  100

Study start: April 2000;  Study completion: June 2005

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   -   65 Years,  Genders Eligible for Study:  Both

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

Location Information


Connecticut
      Department of Psychology, Wesleyan University, Middletown,  Connecticut,  06459,  United States

New York
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States

Study chairs or principal investigators

Michael Terman,  Columbia Presbyterian Medical Center   

More Information

Click here for study information and application

Click here for a description of environmental therapies

Publications

Terman M, Terman JS, Ross DC. A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):875-82.

Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17.

Study ID Numbers:  MH42931A; 5 R01-MH42931A
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  August 11, 2000
ClinicalTrials.gov Identifier:  NCT00006172
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005