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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Light and Ion Therapy for Seasonal Affective Disorder

Conditions
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Seasonal Affective Disorder, Mood Disorders, Depression

Intervention / Treatment
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* Device: bright light box
* Device: dawn simulator
* Device: high-output negative ion generator
* Device: low-output negative ion generator
* Device: dawn light pulse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bright light box<br>30 min exposure shortly after wake-up | Device: bright light box<br>* 10,000 lux bright light therapy<br>|
| Active Comparator: high-output negative ion generator<br>90 min exposure prior to wake-up | Device: high-output negative ion generator<br>* automated air ion delivery in bedroom prior to wake-up<br>|
| Placebo Comparator: low-output negative ion generator<br>90 min exposure prior to wake-up | Device: low-output negative ion generator<br>* automated air ion delivery in bedroom prior to wake-up<br>|
| Active Comparator: dawn simulator<br>naturalistic incremental light exposure 90 min prior to wake-up | Device: dawn simulator<br>* gradual rise in bedroom illumination prior to wake-up<br>|
| Experimental: dawn light pulse<br>rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal | Device: dawn light pulse<br>* rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scale score | reduction from depressed baseline | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of pineal melatonin onset | change from depressed baseline | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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