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Clinical Trials of Two Non-drug Treatments for Chronic Depression

Primary Purpose

Mood Disorders, Depressive Disorders, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright light box
High-output negative ion generator
Low-output negative ion generator
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting, Mood disorders, Phototherapy.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology, Wesleyan University
  • Columbia Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

bright light box

high-output negative ion generator

low-output negative ion generator

Arm Description

60 min light therapy shortly after awakening

60 min high-density exposure shortly after awakening

60 min low-density exposure shortly after awakening

Outcomes

Primary Outcome Measures

Depression scale score
change in score relative to baseline

Secondary Outcome Measures

pineal melatonin onset tme
change in melatonin onset phase relative to baseline

Full Information

First Posted
August 11, 2000
Last Updated
September 30, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00006172
Brief Title
Clinical Trials of Two Non-drug Treatments for Chronic Depression
Official Title
Light and Negative Ion Treatment for Chronic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Depressive Disorders, Depression, Chronic Depression
Keywords
Antidepressive Agents, Chronobiology, Chronotherapy, Circadian rhythms, Depressive Disorder, Ions, Light, Lighting, Mood disorders, Phototherapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bright light box
Arm Type
Active Comparator
Arm Description
60 min light therapy shortly after awakening
Arm Title
high-output negative ion generator
Arm Type
Active Comparator
Arm Description
60 min high-density exposure shortly after awakening
Arm Title
low-output negative ion generator
Arm Type
Placebo Comparator
Arm Description
60 min low-density exposure shortly after awakening
Intervention Type
Device
Intervention Name(s)
Bright light box
Intervention Description
60-min light therapy shortly after awakening
Intervention Type
Device
Intervention Name(s)
High-output negative ion generator
Intervention Description
60-min high-density ion exposure shortly after awakening
Intervention Type
Device
Intervention Name(s)
Low-output negative ion generator
Intervention Description
60-min low-density ion exposure shortly after awakening
Primary Outcome Measure Information:
Title
Depression scale score
Description
change in score relative to baseline
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
pineal melatonin onset tme
Description
change in melatonin onset phase relative to baseline
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Terman
Organizational Affiliation
NYS Psuchiatric Institute
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychology, Wesleyan University
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06459
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9783557
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. doi: 10.1001/archpsyc.55.10.875.
Results Reference
background
PubMed Identifier
9609674
Citation
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.
Results Reference
background
Links:
URL
http://www.cet.org/
Description
Click here for a description of environmental therapies

Learn more about this trial

Clinical Trials of Two Non-drug Treatments for Chronic Depression

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