| What is this
study about?
The
purpose of this study is to see if treatment with artificial bright
light and negative
ions relieves symptoms in patients with chronic depression. These
two treatments have already been successful for patients who become depressed
during winter months, and we believe they also hold great promise for
year-round use.
Participation
is voluntary and treatment is free.
Why
choose an alternative treatment?
It
can be especially frustrating to continue feeling depressed when
antidepressant drugs
haven’t worked. Even with new-generation medications, some people
continue to experience a variety of side effects and unresolved
depression. Or you might just feel uneasy about taking medication
in the first place.
What
are the symptoms?
While
brief periods of feeling "blue" in reaction to life stress
are common, major
depression includes several of the symptoms below, nearly every day
for more than two weeks. In chronic depression, at least some
of the following symptoms have been present most of the time for
at least the
past two years:
- Difficulty
falling asleep, staying asleep, or sleeping too much
- Fatigue or lack
of energy
- Overeating or a
poor appetite
- Significant
weight gain or weight loss although you were not dieting
- Loss of interest
or pleasure in activities
- Feeling down,
sad, or hopeless
- Feeling bad about
yourself or feeling you were letting yourself or family down
- Trouble
concentrating
- Feeling fidgety
or restless (moving around more than normal)
- Moving or
speaking so slowly that other people could have noticed
THE
TREATMENTS:
Clinical
research at the New York State Psychiatric Institute is investigating
two simple, new,
non-drug treatments for chronic depression, all administered at home. If
you are age 18 to 40 and are feeling some
of the symptoms listed above, you might be eligible for this study.
The
treatments include:
Bright
light therapy:
Soon after waking up, you sit at a
special lighting device. While doing this, you can read, write, eat
breakfast, or do any number of other quiet activities.
Negative
air ionization:
Soon after waking up, you sit in front
of a silent electronic device. It works to create atmospheric conditions,
thought to be therapeutic, similar to outdoors.
THE
STUDY PROTOCOL:
You
will be assigned randomly (that is, by chance) to either the bright
light therapy,
high-density negative ion therapy, or low-density negative ion therapy.
It is expected that the antidepressant response to low-density ions will
be lower than for high-density ions and bright light. However, if
at the end of five weeks you have not responded to either light or negative
ion
treatment, you will be given the option of undergoing the alternate
treatment for another five weeks. The informed consent process will
include a discussion of the risks and benefits of participation.
Participants keep
daily records and visit Columbia-Presbyterian Medical Center for
evaluation sessions about every 10 days. Scheduling is flexible.
Ideally you would
enter our program not using antidepressant drugs. However, if your doctor
does not want you to discontinue use, continuation with SSRI’s (for
example, Prozac, Celexa, Paxil) would be acceptable. Of course, this
means that even while using the drug you have remained depressed.
ABOUT
THE CLINICAL CHRONOBIOLOGY PROGRAM:
The
Clinical Chronobiology group is a worldwide leader in developing
innovative,
effective new treatments for depression. Since 1984, we have pioneered
the concept that environmental therapies – supplementing indoor light and
air conditions – leads to an improved mood state in people with
depression. This discovery was made while treating people with winter
depression.
THE
TEAM:
Dr.
Michael Terman, Director, received his Ph.D. degree in physiological
psychology from Brown
University, and is a Professor in the Psychiatry Department at Columbia’s
College of Physicians & Surgeons. He collaborates in his
work with his long-time associate, Dr. Jiuan Su Terman, and their
associates Dr. Ziad
Boulos and Dr. Mila Macchi.
FOR
MORE INFORMATION ABOUT THIS CLINICAL TRIAL,
PLEASE CALL 212-543-6118 #4 or email us at
lightion@pi.cpmc.columbia.edu,
mentioning you interest in the Chronic Depression Study.
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