Clinical Trials of Two Non-drug Treatments for Chronic Depression

NCT ID: NCT00006172

Last Updated: 2014-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2004-02-29

Brief Summary

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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

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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.

Conditions

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Mood Disorders Depressive Disorders Depression Chronic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bright light box

60 min light therapy shortly after awakening

Group Type ACTIVE_COMPARATOR

Bright light box

Intervention Type DEVICE

60-min light therapy shortly after awakening

high-output negative ion generator

60 min high-density exposure shortly after awakening

Group Type ACTIVE_COMPARATOR

High-output negative ion generator

Intervention Type DEVICE

60-min high-density ion exposure shortly after awakening

low-output negative ion generator

60 min low-density exposure shortly after awakening

Group Type PLACEBO_COMPARATOR

Low-output negative ion generator

Intervention Type DEVICE

60-min low-density ion exposure shortly after awakening

Interventions

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Bright light box

60-min light therapy shortly after awakening

Intervention Type DEVICE

High-output negative ion generator

60-min high-density ion exposure shortly after awakening

Intervention Type DEVICE

Low-output negative ion generator

60-min low-density ion exposure shortly after awakening

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Terman

Role: STUDY_DIRECTOR

NYS Psuchiatric Institute

Locations

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Department of Psychology, Wesleyan University

Middletown, Connecticut, United States

Site Status

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archpsyc.55.10.875.

Reference Type BACKGROUND
PMID: 9783557 (View on PubMed)

Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.

Reference Type BACKGROUND
PMID: 9609674 (View on PubMed)

Related Links

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http://www.cet.org/

Click here for a description of environmental therapies

Other Identifiers

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R01MH042931-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#3554/R01 MH42931-02

Identifier Type: -

Identifier Source: org_study_id

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