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OpenTrials
Completed

NCT Number: NCT00006172

Clinical Trials of Two Non-drug Treatments 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright light box

Device

60-min light therapy shortly after awakening

high-output negative ion generator

Device

60-min high-density ion exposure shortly after awakening

low-output negative ion generator

Device

60-min low-density ion exposure shortly after awakening

Primary outcomes

  1. Depression scale score

    Time frame: 5 weeks

    change in score relative to baseline

Secondary outcomes

  1. pineal melatonin onset tme

    Time frame: 5 weeks

    change in melatonin onset phase relative to baseline

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Light and Negative Ion Treatment for Chronic Depression

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
Aug 14, 2000
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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