Clinical trial NCT00006172: Clinical Trials of Two Non-drug Treatments for Chronic Depression
Official title: Light and Negative Ion Treatment for Chronic Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Depressive Disorders
Depression
Chronic Depression
Keywords: Antidepressive Agents
Chronobiology
Chronotherapy
Circadian rhythms
Depressive Disorder
Ions
Light
Lighting
Mood disorders
Phototherapy.
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2000-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.

Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Depression scale score
timeFrame: 5 weeks
Secondary outcomes:
measure: pineal melatonin onset tme
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Department of Psychology, Wesleyan University
state: Connecticut
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
Study officials:
affiliation: NYS Psuchiatric Institute
name: Michael Terman
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.