"More people are turning to St. John's wort as a treatment for their depressive symptoms than ever before, and the majority of them do so without consulting a physician," said Davidson. "It is vitally important to conduct well-designed studies to examine herbal supplements and other drugs for the treatment of depression, which is a common and sometimes debilitating illness."
Previous studies of SJW, performed largely in Europe and many of which had positive findings, have not clearly characterized the types of depression that might respond to this treatment.
The Duke-led study sought to address these issues through a placebo-controlled examination of a specific extract of hypericum against the SSRI control, and by providing controlled data from patients who were monitored for a minimum of eight weeks and a maximum of six months. Among the 12 study sites, 340 participants were enrolled.
The study consisted of a randomized, double blind, parallel group, eight-week, outpatient trial of SJW, sertraline, and placebo for the treatment of major depression. The initial treatment was followed by up to 18 weeks of double-blind continuation treatment in those participants who were responding favorably to medication at eight weeks. Patients were recruited from 12 academic or community clinics.
To be considered for the study, outpatients must have had a diagnosis of major depression, have a minimum score of 20 on the Hamilton Depression (HAM-D) scale (a 17-item scale used to evaluate depression) and a maximum score of 60 on the Global Assessment of Functioning (GAF) scale (used to measure a person's level of functioning or distress) at the time they were screened and at baseline. Participants were carefully screened and excluded based on various criteria including suicide risk, previous non-responsiveness to medications, diagnoses of other disorders such as schizophrenia
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Contact: Tracey Koepke
koepk002@mc.duke.edu
919-684-4148
Duke University
9-Apr-2002