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Completed Not applicable Interventional

Treatment of Major Depression With St. John's Wort (Hypericum)

ClinicalTrials.gov ID: NCT00005013

Public ClinicalTrials.gov record NCT00005013. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Placebo Controlled Clinical Trial of a Standardized Extract of Hypericum Perforatum in Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00005013
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 1998
Primary completion
Not listed
Completion
Jun 30, 2001
Last update posted
Apr 7, 2014

1998 – 2001

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Feighner Research Institute San Diego California 92121
Stanford Univ School of Medicine Stanford California 94305
Harbor-UCLA Rsch and Education Inst Torrance California 90502
Univ of South Florida College of Med Tampa Florida 33613
Emory Mood and Anxiety Disorders Clinical Trials Program Atlanta Georgia 30329
McLean Hospital Belmont Massachusetts 02478
Eastside Comprehensive Medical Services New York New York 10021
Duke Univ Med Ctr Durham North Carolina 27710
Univ of Cincinnati Medical Ctr Cincinnati Ohio 45267
Univ of Texas Southwestern Med Ctr Dallas Texas 75235
Seattle Clinical Research Center Seattle Washington 98104
Dean Foundation for Hlth Rsch and Education Middleton Wisconsin 53562

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00005013, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 7, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00005013 live on ClinicalTrials.gov.

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