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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00006517
First received: November 22, 2000
Last updated: September 30, 2014
Last verified: November 2005
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light and Ion Therapy for Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Depression scale score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    reduction from depressed baseline


Secondary Outcome Measures:
  • time of pineal melatonin onset [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    change from depressed baseline


Enrollment: 150
Study Start Date: September 1998
Study Completion Date: April 2004
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006517

Locations
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Michael Terman Columbia University
  More Information

Additional Information:
Publications:
Caldwell M. Mind over time. Discover Magazine, July 1999;50-59. <http://www.discover.com/july_99/featmind.html>
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>

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00006517     History of Changes
Other Study ID Numbers: #3032/R01 MH42931-01, R01MH042931-01
Study First Received: November 22, 2000
Last Updated: September 30, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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
Phototherapy
Dawn Simulation therapy
Negative air ionization therapy
Chronobiology
Biological rhythms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Mood Disorders
Seasonal Affective Disorder
Behavioral Symptoms
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014