New trial will evaluate safety and effectiveness of the herb Saint John’s wort and the antidepressant citalopram for minor depression
The National
Institute of Mental Health is starting a multicenter study on treatment
for minor depression: The 4-year trial will evaluate the safety and
effectiveness of Saint John’s wort, an herbal supplement, and citalopram,
a standard antidepressant, compared with placebo. A
total of 300 participants with minor depression will be randomized
to a standardized extract of St. John's wort (Hypericum perforatum),
citalopram, or placebo in a 12-
week double-blind trial. Researchers will assess changes in patients'
symptoms, function, and quality of life. Patients who show no improvement
on one active treatment will receive the other active treatment,
while patients with improved symptoms will take the original treatment
for an additional 14 weeks.
Minor depression is a common disorder that
may impair a person's function and quality of life. In addition,
it is a serious risk factor for major depression. Yet it is underdiagnosed
and undertreated in the U.S. The current study addresses a need
for definitive data on therapy for this significant health problem.
Patients with minor depression who seek treatment from family doctors
are often treated with prescription
antidepressants, if their mood disorder is diagnosed at all. Many
people use St. John's wort without consulting a physician. This
study will help determine how the herbal
agent and the antidepressant fit in the overall management of the
disorder.
"If the trial demonstrates that citalopram
or St. John's wort benefits patients with minor depression, it will
expand our understanding of this under-recognized mood disorder
and offer new evidence-based treatment recommendations for either
primary care or mental health clinicians," explained Matthew
Rudorfer, M.D., of the National Institutes of Health.
Men and women ages 18 to 85 years who meet
diagnostic criteria for minor depression are eligible to participate.
They must have experienced depressive symptoms for at least 6 months
but less than 2 years continuously without meeting criteria for
a major depressive episode or dysthymia within the past year.
Additional exclusionary criteria include other
mental disorders such as schizophrenia, bipolar disorder, anxiety,
and substance use disorders. Individuals with some active
physical illnesses, such as cardiovascular, renal, respiratory,
endocrine, neurological, or blood diseases also are not eligible
for the study.
Participants are interviewed at an initial
screening visit, during the initial two-week period when they are
withdrawn from all psychotropic medications, at baseline, and every
2 weeks thereafter during the study. At the screening visit, Week
12, and Week 20, patients will undergo a complete blood count with
laboratory tests. Well validated
scales will be used to assess symptoms, dysfunction, and well-being.
Experts estimate that minor depression affects
about 7.5 percent of Americans during their lifetime.
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