Clinical Trials of Two Non-drug Treatments for Chronic Depression

Depression Clinical Trial

Official title:

Light and Negative Ion Treatment for Chronic Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006172
• Other study ID #: #3554/R01 MH42931-02
• Secondary ID: R01MH042931-02
• Status: Completed
• Phase: N/A
• First received: August 11, 2000
• Last updated: September 30, 2014
• Start date: April 2000
• Est. completion date: February 2004

Study information

• Verified date: March 2008
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2004
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Depression
• Depression
• Depressive Disorder
• Depressive Disorders
• Disease
• Mood Disorders

Intervention

Device:
• Bright light box
60-min light therapy shortly after awakening
• High-output negative ion generator
60-min high-density ion exposure shortly after awakening
• Low-output negative ion generator
60-min low-density ion exposure shortly after awakening

Locations

Country	Name	City	State
United States	Department of Psychology, Wesleyan University	Middletown	Connecticut
United States	Columbia Presbyterian Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression scale score	change in score relative to baseline	5 weeks	No
Secondary	pineal melatonin onset tme	change in melatonin onset phase relative to baseline	5 weeks	No

External Links

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