Light and Ion Therapy for Seasonal Affective Disorder
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
Sponsors
Lead Sponsor
Collaborators
Source
New York State Psychiatric Institute
Oversight Info
Has Dmc
No
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.
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.
Overall Status
Completed
Start Date
1998-09-01
Completion Date
2004-04-01
Primary Completion Date
2003-06-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Depression scale score |
3 weeks |
Secondary Outcome
Measure |
Time Frame |
time of pineal melatonin onset |
3 weeks |
Enrollment
150
Conditions
Intervention
Intervention Type
Device
Intervention Name
Description
10,000 lux bright light therapy
Arm Group Label
bright light box
Intervention Type
Device
Intervention Name
Description
gradual rise in bedroom illumination prior to wake-up
Arm Group Label
dawn simulator
Intervention Type
Device
Intervention Name
Description
automated air ion delivery in bedroom prior to wake-up
Arm Group Label
high-output negative ion generator
Intervention Type
Device
Intervention Name
Description
automated air ion delivery in bedroom prior to wake-up
Arm Group Label
low-output negative ion generator
Intervention Type
Device
Intervention Name
Description
rectangular light pulse matched for lux.time of dawn simulation delivered prior towake-up
Arm Group Label
dawn light pulse
Eligibility
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
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
Michael Terman |
Principal Investigator |
Columbia University |
Location
Facility |
Columbia Presbyterian Medical Center New York New York 10032 United States |
Location Countries
Country
United States
Verification Date
2005-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
R01MH042931-01
Number Of Arms
5
Arm Group
Arm Group Label
bright light box
Arm Group Type
Active Comparator
Description
30 min exposure shortly after wake-up
Arm Group Label
high-output negative ion generator
Arm Group Type
Active Comparator
Description
90 min exposure prior to wake-up
Arm Group Label
low-output negative ion generator
Arm Group Type
Placebo Comparator
Description
90 min exposure prior to wake-up
Arm Group Label
dawn simulator
Arm Group Type
Active Comparator
Description
naturalistic incremental light exposure 90 min prior to wake-up
Arm Group Label
dawn light pulse
Arm Group Type
Experimental
Description
rectangular pulse light exposure 13 min before wake-up, matched for total illuminance with dawn signal
Firstreceived Results Date
N/A
Reference
Citation
Caldwell M. Mind over time. Discover Magazine, July 1999;50-59.
Citation
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. Review.
PMID
7632987
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.
PMID
9783557
Citation
Terman M; Terman JS; Williams JBW. Seasonal affective disorder and its treatments. J Pract Psychiatry Behav Health 1998;5:387-303.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
November 22, 2000
Study First Submitted Qc
November 22, 2000
Study First Posted
November 23, 2000
Last Update Submitted
June 2, 2015
Last Update Submitted Qc
June 2, 2015
Last Update Posted
June 3, 2015
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.