- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006517
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
Light and Ion Therapy for Seasonal Affective Disorder
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia Presbyterian Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: bright light box
30 min exposure shortly after wake-up
|
10,000 lux bright light therapy
|
Active Comparator: high-output negative ion generator
90 min exposure prior to wake-up
|
automated air ion delivery in bedroom prior to wake-up
|
Placebo Comparator: low-output negative ion generator
90 min exposure prior to wake-up
|
automated air ion delivery in bedroom prior to wake-up
|
Active Comparator: dawn simulator
naturalistic incremental light exposure 90 min prior to wake-up
|
gradual rise in bedroom illumination prior to wake-up
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Experimental: dawn light pulse
rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal
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rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression scale score
Time Frame: 3 weeks
|
reduction from depressed baseline
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of pineal melatonin onset
Time Frame: 3 weeks
|
change from depressed baseline
|
3 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Terman, Columbia University
Publications and helpful links
General Publications
- Caldwell M. Mind over time. Discover Magazine, July 1999;50-59. <http://www.discover.com/july_99/featmind.html>
- 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.
- 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.
- 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>
Helpful Links
- 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.
- Click here for information about SAD and its treatments, presented by the Center for Environmental Therapeutics, a 501(c)(3) nonprofit professional agency.
- 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).
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #3032/R01 MH42931-01
- R01MH042931-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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