NCT00006172

Brief Summary

This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

October 1, 2014

Status Verified

March 1, 2008

Enrollment Period

3.2 years

First QC Date

August 11, 2000

Last Update Submit

September 30, 2014

Conditions

Keywords

Antidepressive AgentsChronobiologyChronotherapyCircadian rhythmsDepressive DisorderIonsLightLightingMood disordersPhototherapy.

Outcome Measures

Primary Outcomes (1)

  • Depression scale score

    change in score relative to baseline

    5 weeks

Secondary Outcomes (1)

  • pineal melatonin onset tme

    5 weeks

Study Arms (3)

bright light box

ACTIVE COMPARATOR

60 min light therapy shortly after awakening

Device: Bright light box

high-output negative ion generator

ACTIVE COMPARATOR

60 min high-density exposure shortly after awakening

Device: High-output negative ion generator

low-output negative ion generator

PLACEBO COMPARATOR

60 min low-density exposure shortly after awakening

Device: Low-output negative ion generator

Interventions

60-min light therapy shortly after awakening

bright light box

60-min high-density ion exposure shortly after awakening

high-output negative ion generator

60-min low-density ion exposure shortly after awakening

low-output negative ion generator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of major depression
  • Must be able to maintain a regular sleep schedule

You may not qualify if:

  • Depression restricted to certain seasons of the year
  • Presence of other psychiatric disorders
  • Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
  • Current use of recreational drugs or supplements that may affect mood
  • Current medical illness or medication that may affect response to antidepressant treatment
  • Long-distance travel while participating in the program
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Psychology, Wesleyan University

Middletown, Connecticut, 06459, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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: 9783557BACKGROUND
  • Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.

    PMID: 9609674BACKGROUND

Related Links

MeSH Terms

Conditions

Mood DisordersDepressive DisorderDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Michael Terman

    NYS Psuchiatric Institute

    STUDY DIRECTOR

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

August 11, 2000

First Posted

August 14, 2000

Study Start

April 1, 2000

Primary Completion

July 1, 2003

Study Completion

February 1, 2004

Last Updated

October 1, 2014

Record last verified: 2008-03

Locations