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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