Clinical Trials of Two Non-drug Treatments for Chronic Depression

Not Applicable

Completed

• Conditions: Mood Disorders; Depressive Disorders; Depression; Chronic Depression
• Interventions: Device: Low-output negative ion generator; Device: High-output negative ion generator; Device: Bright light box

• Registration Number: NCT00006172
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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.

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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-08-11
• Study First Submitted QC: 2000-08-11
• Study First Posted: 2000-08-14
• Primary Completion: 2003-07
• Study Completion: 2004-02
• Status Verified: 2008-03
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-output negative ion generator	Low-output negative ion generator	60 min low-density exposure shortly after awakening
high-output negative ion generator	High-output negative ion generator	60 min high-density exposure shortly after awakening
bright light box	Bright light box	60 min light therapy shortly after awakening

Primary Outcome Measures

Name	Time	Method
Depression scale score	5 weeks	change in score relative to baseline

Secondary Outcome Measures

Name	Time	Method
pineal melatonin onset tme	5 weeks	change in melatonin onset phase relative to baseline

Trial Locations

Locations (2)

Department of Psychology, Wesleyan University; 🇺🇸 Middletown, Connecticut, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States