Treatment of Major Depression With St. John's Wort (Hypericum)
Status:
Completed
Trial end date:
2001-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Mental Health (NIMH)
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)