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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2004-04-30

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.

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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.

Conditions

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Seasonal Affective Disorder Mood Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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bright light box

30 min exposure shortly after wake-up

Group Type ACTIVE_COMPARATOR

bright light box

Intervention Type DEVICE

10,000 lux bright light therapy

high-output negative ion generator

90 min exposure prior to wake-up

Group Type ACTIVE_COMPARATOR

high-output negative ion generator

Intervention Type DEVICE

automated air ion delivery in bedroom prior to wake-up

low-output negative ion generator

90 min exposure prior to wake-up

Group Type PLACEBO_COMPARATOR

low-output negative ion generator

Intervention Type DEVICE

automated air ion delivery in bedroom prior to wake-up

dawn simulator

naturalistic incremental light exposure 90 min prior to wake-up

Group Type ACTIVE_COMPARATOR

dawn simulator

Intervention Type DEVICE

gradual rise in bedroom illumination prior to wake-up

dawn light pulse

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

Group Type EXPERIMENTAL

dawn light pulse

Intervention Type DEVICE

rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up

Interventions

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bright light box

10,000 lux bright light therapy

Intervention Type DEVICE

dawn simulator

gradual rise in bedroom illumination prior to wake-up

Intervention Type DEVICE

high-output negative ion generator

automated air ion delivery in bedroom prior to wake-up

Intervention Type DEVICE

low-output negative ion generator

automated air ion delivery in bedroom prior to wake-up

Intervention Type DEVICE

dawn light pulse

rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No