NIMH St. John's wort study RFP outlines eight-week trial for "major depressive disorder".
This article was originally published in The Tan Sheet
Executive Summary
ST. JOHN's WORT DEPRESSION ACUTE TREATMENT STUDY will compare the safety and clinical efficacy of eight weeks of daily treatment with 900 mg standardized Hypericum perforatum, or St. John's wort, a botanical dietary supplement commonly used as an antidepressant, to placebo in patients found to suffer from a major depressive disorder. The three-arm trial, sponsored by the National Institute of Mental Health, will include an examination in the third arm of patients receiving eight weeks of treatment with a prescription selective serotonin re-uptake inhibitor (SSRI) antidepressant "to document the sensitivity of the trial," NIMH said. However, "this trial will not have sufficient power to compare SSRI to Hypericum," the study protocol states.