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Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)

Primary Purpose

Seasonal Affective Disorder, Mood Disorders, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bright light box
dawn simulator
high-output negative ion generator
low-output negative ion generator
dawn light pulse
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring Seasonal Affective Disorder (SAD), Winter Depression, Mood disorders, Bipolar I and II disorders, Major Depressive Disorder, Recurrent, Light therapy, Phototherapy, Dawn Simulation therapy, Negative air ionization therapy, Chronobiology, Biological rhythms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring Able to maintain a regular sleep schedule Exclusion Criteria: Presence of psychiatric disorders other than major depression or bipolar depression Current use of antidepressant or recreational drugs, or psychotropic medication or supplements that may affect mood Current medical illness or medication that might interfere with response to treatment Long-distance travel during the program

Sites / Locations

  • Columbia Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Experimental

Arm Label

bright light box

high-output negative ion generator

low-output negative ion generator

dawn simulator

dawn light pulse

Arm Description

30 min exposure shortly after wake-up

90 min exposure prior to wake-up

90 min exposure prior to wake-up

naturalistic incremental light exposure 90 min prior to wake-up

rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal

Outcomes

Primary Outcome Measures

Depression scale score
reduction from depressed baseline

Secondary Outcome Measures

time of pineal melatonin onset
change from depressed baseline

Full Information

First Posted
November 22, 2000
Last Updated
June 2, 2015
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00006517
Brief Title
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
Official Title
Light and Ion Therapy for Seasonal Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
April 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
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter. The treatments are self-administered at home by the patient, with close clinical supervision. Our trials use specially designed devices that replenish two different environmental elements, naturally occurring light and negative ions in the air. Both factors may be reduced in winter, bringing on depression.
Detailed Description
The treatments we are investigating include bright light therapy upon awakening, and two contrasting treatments during the final hours of sleep: negative air ionization (provided at two levels) and dawn simulation (also at two levels), both switched on by a silent electronic timer or microprocessor. We hypothesize that the reduced outdoor light availability in winter, as well as reduced concentration of negative ions in the air circulation are both factors that contribute to depression. By supplementing the indoor environment with either ions or light, we are aiming to recreate summer-like conditions that are therapeutic. Our past studies have shown all three methods to have antidepressant effects in patients with seasonal affective disorder (SAD). Unlike light therapy, negative air ionization is imperceptible (you cannot sense when the ionizer is active). Applications to the program are accepted and reviewed throughout the year. Screening interviews for entry into the program are scheduled between August and February. Patients and researchers both benefit most when applications are received by the start of the individual's "problem season," because this leaves maximum time to explore alternate treatments. Candidates undergo a two-hour personal interview at Columbia-Presbyterian Medical Center that ascertains whether they meet inclusion criteria. At a second two-hour visit we provide a standard medical examination including blood tests, urinalysis and EKG, all without cost. As an alternative, physicals may be performed by one's personal physician. Once the study is underway, there are about five additional one-hour appointments for clinical evaluations, flexibly scheduled during the business day, usually about 10 days apart. We provide the treatment apparatus on loan. All treatments are scheduled in the morning around the time of awakening. The bedroom treatments (negative ions or dawn simulation) end by the time of awakening. The bright light treatment takes place for half an hour after waking up. Initially, patients are randomly assigned to one of the treatment groups. The treatment must be taken consistently for three weeks at the same time every day, after which it is temporarily suspended to determine whether symptoms return. Given sufficient time within the winter season, patients then have the opportunity to try one of the alternate treatments to determine which works best for them. This provides an informed, confident basis for a treatment plan for subsequent years. As part of the protocol, patients provide saliva samples on two evenings, which are used to test for the level of melatonin, a hormone that becomes active at night. Results reveal whether a person's internal circadian rhythm is early, late or normal, information that can be used to guide the timing of future treatment. This constitutes a distinct benefit for research participants, since such a diagnostic test is not yet available in medical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder, Mood Disorders, Depression
Keywords
Seasonal Affective Disorder (SAD), Winter Depression, Mood disorders, Bipolar I and II disorders, Major Depressive Disorder, Recurrent, Light therapy, Phototherapy, Dawn Simulation therapy, Negative air ionization therapy, Chronobiology, Biological rhythms

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
bright light box
Arm Type
Active Comparator
Arm Description
30 min exposure shortly after wake-up
Arm Title
high-output negative ion generator
Arm Type
Active Comparator
Arm Description
90 min exposure prior to wake-up
Arm Title
low-output negative ion generator
Arm Type
Placebo Comparator
Arm Description
90 min exposure prior to wake-up
Arm Title
dawn simulator
Arm Type
Active Comparator
Arm Description
naturalistic incremental light exposure 90 min prior to wake-up
Arm Title
dawn light pulse
Arm Type
Experimental
Arm Description
rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal
Intervention Type
Device
Intervention Name(s)
bright light box
Intervention Description
10,000 lux bright light therapy
Intervention Type
Device
Intervention Name(s)
dawn simulator
Intervention Description
gradual rise in bedroom illumination prior to wake-up
Intervention Type
Device
Intervention Name(s)
high-output negative ion generator
Intervention Description
automated air ion delivery in bedroom prior to wake-up
Intervention Type
Device
Intervention Name(s)
low-output negative ion generator
Intervention Description
automated air ion delivery in bedroom prior to wake-up
Intervention Type
Device
Intervention Name(s)
dawn light pulse
Intervention Description
rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
Primary Outcome Measure Information:
Title
Depression scale score
Description
reduction from depressed baseline
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
time of pineal melatonin onset
Description
change from depressed baseline
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of major depression or bipolar disorder, with regular onset of depression in fall or winter and remission in spring Able to maintain a regular sleep schedule Exclusion Criteria: Presence of psychiatric disorders other than major depression or bipolar depression Current use of antidepressant or recreational drugs, or psychotropic medication or supplements that may affect mood Current medical illness or medication that might interfere with response to treatment Long-distance travel during the program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Terman
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
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:
Citation
Caldwell M. Mind over time. Discover Magazine, July 1999;50-59. <http://www.discover.com/july_99/featmind.html>
Results Reference
background
PubMed Identifier
7632987
Citation
Terman M, Lewy AJ, Dijk DJ, Boulos Z, Eastman CI, Campbell SS. Light treatment for sleep disorders: consensus report. IV. Sleep phase and duration disturbances. J Biol Rhythms. 1995 Jun;10(2):135-47. doi: 10.1177/074873049501000206.
Results Reference
background
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
Citation
Terman M; Terman JS; Williams JBW. Seasonal affective disorder and its treatments. J Pract Psychiatry Behav Health 1998;5:387-303. <http://www.practicalpsychiatry.com>
Results Reference
background
Links:
URL
http://www.columbiapsychiatry.org/cs/cltbr.html
Description
Click here for more information about our study. Also, you can print out a confidential preliminary application to mail or fax to our center for quick review.
URL
http://www.cet.org/
Description
Click here for information about SAD and its treatments, presented by the Center for Environmental Therapeutics, a 501(c)(3) nonprofit professional agency.
URL
http://www.practicalpsychiatry.com/
Description
Background reference: Click hear to read the abstract of Dr. Terman's article, "Seasonal Affective Disorder and its Treatments," in the Journal of Practical Psychiatry and Behavioral Health (at the site, click on "Contents," September 1998).

Learn more about this trial

Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)

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