Posted on: 03/21/2003
BETHESDA, Md.–The National Institute of Mental Health (NIMH), a branch of the National Institutes of Health (NIH), is seeking volunteers with mild depression to participate in a double blind trial that was organized to determine the safety and efficacy of St. John's wort in comparison to placebo or citalopram (a selective serotonin reuptake inhibitor known by the brand name Celexa™ and available from Forest Pharmaceuticals Inc.). The study will help determine how the herb and the antidepressant fit in the overall management of the disorder.
"There is high public interest in herbal remedies for depression," said Stephen E. Straus, M.D., director at the National Center for Complementary and Alternative Medicine (NCCAM), which is co-sponsoring the study with the Office of Dietary Supplements (ODS) and NIMH. "Our intent is to study St. John's wort for the spectrum of depressive conditions for which the public considers its use. This new study extends our earlier research efforts from the more serious form of depression to a clinically less serious one, yet one that is, in fact, of considerable public health significance."
The earlier research mentioned by Straus consisted of a study published in the April 10, 2002, issue of the Journal of the American Medical Association (287, 14:1807-14, 2002). Researchers from the Duke University Medical Center in Durham, N.C., concluded neither St. John's wort nor sertraline (the antidepressant Zoloft®, manufactured by Pfizer Inc.) was effective for treating severe depression.
The upcoming $4 million collaborative study will involve trials conducted at centers in Boston, Los Angeles and Pittsburgh. Volunteers will be randomly assigned to St. John's wort, citalopram or placebo for a 12-week period, during which time researchers will assess changes in patients' symptoms, functioning and quality of life. Those subjects demonstrating improvements will continue their regimen for another 14 weeks.
"Herbal medicines are something to reach for when the doctor is going to overmedicate you," said Stephen Dentali, Ph.D., vice president of scientific and technical affairs at the American Herbal Products Association. "Our medical system is great when you're really sick, they know how to fix it. But when you're not quite there yet, and you need a mild antidepressant rather than a strong one, it would be really nice to know if St. John's wort works because in terms of the profile of side effects, there's no comparison. If St. John's wort is one-fifth as active but has one-tenth of the side effects [of traditional antidepressant therapy], maybe it's just the thing. I'm hoping this trial will show if that's the case."
NIH researchers are recruiting a total of 300 volunteers who are healthy but suffering from mild depression. Finding the "ideal" subject is important for a clinical trial such as this one, according to Dentali. This particular trial will exclude subjects who have mental disorders other than depression, such as schizophrenia, bipolar disorder, anxiety or substance use disorders. Subjects will also be excluded if they have active physical illnesses, such as cardiovascular, renal, respiratory, endocrine, neurological or blood diseases.
"When you're including other variables, as in any scientific study, it makes it harder to get your answer," Dentali said. "An ideal patient for a trial such as this one would be a healthy person that is mildly depressed–mostly the people who take St. John's wort. When you're studying an herbal product in the way that more closely represents how people use it, the results would tend to be more meaningful than if you don't."