Treatment of Major Depression With St. John's Wort (Hypericum)
The purpose of this trial is to study the acute efficacy and safety of a standardized extract of the herb Hypericum perforatum (St. John's Wort), called hypericum for purposes of this trial, in the treatment of patients with major depression.
Clinical depression is a serious medical disorder that can be debilitating and can lead to suicide. There is growing public interest in claims that hypericum may be an effective treatment for depression. Although it is widely prescribed in Europe, no studies of its long-term use have been conducted, and published studies have treated different types of patients and have used several different doses. The toxicity and side effects of hypericum appear to be substantially less than those of standard tricyclic antidepressant medications, and thus hypericum may be more acceptable to patients. In addition, the cost is significantly less than standard antidepressant medications. Published studies assessed acute efficacy and lasted between 4 and 12 weeks (most being 4-6 weeks). The longer-term effects of hypericum have not been evaluated. There is a need for a large-scale, controlled clinical trial to assess whether Hypericum has a significant therapeutic effect in patients with clinical depression.
Patients are assigned randomly (like tossing a coin) to receive St. John's wort, Sertraline (Zoloft), or a placebo (sugar pill) for 8 weeks. This is a double-blind study, meaning neither the patient nor the doctor will know which treatment is being assigned. Patients who respond well to the treatment will continue on the assigned treatment for an additional 4 months. Patients will have regular follow-up visits to monitor their symptoms and any side effects they experience.
Drug: Hypericum perforatum (St. John's wort)
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Placebo Controlled Clinical Trial of a Standardized Extract of Hypericum Perforatum in Major Depressive Disorder|
|Study Start Date:||December 1998|
|Study Completion Date:||July 2001|
This trial will determine the acute antidepressant efficacy of a standardized extract of hypericum (St. John's Wort) for the treatment of major depressive disorder.
For this trial, the primary efficacy analysis will be evaluated at 8 weeks. For observational purposes, a 4-month double blind continuation (6 months total treatment) in treatment responders would enable an approximation of the effectiveness of maintenance treatment with this medication. No published studies have included a selective serotonin re-uptake inhibitor (SSRI) comparator. While this trial will not compare the efficacy of hypericum to an SSRI, having an SSRI arm of sertraline (Zoloft) will allow an evaluation of the validity of the trial.
336 eligible patients will be randomly assigned to double-blind treatment with hypericum, sertraline, or placebo following a one-week placebo lead-in period (between screening and baseline). All treatment groups will consist of 112 patients and will be followed for an eight-week period. Treatment responders will be continued on the randomly assigned treatment arm for an additional 18 weeks.
|United States, California|
|Feighner Research Institute|
|San Diego, California, United States, 92121|
|Stanford Univ School of Medicine|
|Stanford, California, United States, 94305|
|Harbor-UCLA Rsch and Education Inst|
|Torrance, California, United States, 90502|
|United States, Florida|
|Univ of South Florida College of Med|
|Tampa, Florida, United States, 33613|
|United States, Georgia|
|Emory Mood and Anxiety Disorders Clinical Trials Program|
|Atlanta, Georgia, United States, 30329|
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|United States, New York|
|Eastside Comprehensive Medical Services|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke Univ Med Ctr|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Univ of Cincinnati Medical Ctr|
|Cincinnati, Ohio, United States, 45267|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr|
|Dallas, Texas, United States, 75235|
|United States, Washington|
|Seattle Clinical Research Center|
|Seattle, Washington, United States, 98104|
|United States, Wisconsin|
|Dean Foundation for Hlth Rsch and Education|
|Middleton, Wisconsin, United States, 53562|
|Principal Investigator:||Jonathan Davidson||Duke Univ Med Ctr|