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

NCT00006517 | Completed

• 2 other identifiers: #3032/R01 MH42931-01R01MH042931-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Affective Disorder; Mood Disorders; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Depression scale score

  reduction from depressed baseline

  3 weeks

Secondary Outcomes (1)

• time of pineal melatonin onset

  3 weeks

Study Arms (5)

bright light box

ACTIVE COMPARATOR

30 min exposure shortly after wake-up

Device: bright light box

high-output negative ion generator

ACTIVE COMPARATOR

90 min exposure prior to wake-up

Device: high-output negative ion generator

low-output negative ion generator

PLACEBO COMPARATOR

90 min exposure prior to wake-up

Device: low-output negative ion generator

dawn simulator

ACTIVE COMPARATOR

naturalistic incremental light exposure 90 min prior to wake-up

Device: dawn simulator

dawn light pulse

EXPERIMENTAL

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

Device: dawn light pulse

Interventions

bright light box DEVICE

10,000 lux bright light therapy

bright light box

dawn simulator DEVICE

gradual rise in bedroom illumination prior to wake-up

dawn simulator

high-output negative ion generator DEVICE

automated air ion delivery in bedroom prior to wake-up

high-output negative ion generator

low-output negative ion generator DEVICE

automated air ion delivery in bedroom prior to wake-up

low-output negative ion generator

dawn light pulse DEVICE

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

dawn light pulse

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

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

  BACKGROUND

• 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.

  PMID: 7632987 BACKGROUND

• 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.

  PMID: 9783557 BACKGROUND

• 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>

  BACKGROUND

Related 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).

MeSH Terms

Conditions

Seasonal Affective Disorder; Mood Disorders; Depression; Depressive Disorder, Major; Recurrence

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Terman

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2000
• First Posted: November 23, 2000
• Study Start: September 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: April 1, 2004
• Last Updated: June 3, 2015

Record last verified: 2005-11

Locations

US (1)