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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006517
Recruitment Status : Completed
First Posted : November 23, 2000
Last Update Posted : June 3, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Mood Disorders Depression Device: bright light box Device: dawn simulator Device: high-output negative ion generator Device: low-output negative ion generator Device: dawn light pulse Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light and Ion Therapy for Seasonal Affective Disorder
Study Start Date : September 1998
Actual Primary Completion Date : June 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: bright light box
30 min exposure shortly after wake-up
Device: bright light box
10,000 lux bright light therapy

Active Comparator: high-output negative ion generator
90 min exposure prior to wake-up
Device: high-output negative ion generator
automated air ion delivery in bedroom prior to wake-up

Placebo Comparator: low-output negative ion generator
90 min exposure prior to wake-up
Device: low-output negative ion generator
automated air ion delivery in bedroom prior to wake-up

Active Comparator: dawn simulator
naturalistic incremental light exposure 90 min prior to wake-up
Device: dawn simulator
gradual rise in bedroom illumination prior to wake-up

Experimental: dawn light pulse
rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal
Device: dawn light pulse
rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up

Primary Outcome Measures :
  1. Depression scale score [ Time Frame: 3 weeks ]
    reduction from depressed baseline

Secondary Outcome Measures :
  1. time of pineal melatonin onset [ Time Frame: 3 weeks ]
    change from depressed baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006517

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United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
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Principal Investigator: Michael Terman Columbia University
Additional Information:
Caldwell M. Mind over time. Discover Magazine, July 1999;50-59. <>
Terman M; Terman JS; Williams JBW. Seasonal affective disorder and its treatments. J Pract Psychiatry Behav Health 1998;5:387-303. <>

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Responsible Party: New York State Psychiatric Institute Identifier: NCT00006517    
Other Study ID Numbers: #3032/R01 MH42931-01
R01MH042931-01 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2000    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: November 2005
Keywords provided by New York State Psychiatric Institute:
Seasonal Affective Disorder (SAD)
Winter Depression
Mood disorders
Bipolar I and II disorders
Major Depressive Disorder, Recurrent
Light therapy
Dawn Simulation therapy
Negative air ionization therapy
Biological rhythms
Additional relevant MeSH terms:
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Depressive Disorder
Mood Disorders
Seasonal Affective Disorder
Pathologic Processes
Behavioral Symptoms
Mental Disorders