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NCT00005013 · ClinicalTrials.gov registry record · NA
Treatment of Major Depression With St. John's Wort (Hypericum)
A NA study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- NA
- Development phase
NCT00005013 is a NA study that has completed, run by National Institute of Mental Health (NIMH).
The verdict
NCT00005013, a NA study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- NA
- Development phase
Study 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.
Interventions
- DRUG Sertraline
- DRUG Hypericum perforatum (St. John's wort)
Trial Details
| Field | Value |
|---|---|
| Start Date | 1998-12 |
| Est. Completion | 2001-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005013
The ClinicalTrials.gov registry entry for NCT00005013 describes a study currently listed as completed, categorized as NA. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT00005013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005013 about?
NCT00005013 is a clinical study titled "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 c...
What is the current status of trial NCT00005013?
This trial is currently completed. It is a NA study. The study started on 1998-12. Estimated completion is 2001-07.
What interventions are being tested in trial NCT00005013?
The interventions under investigation include: Sertraline (DRUG), Hypericum perforatum (St. John's wort) (DRUG).
Who is sponsoring clinical trial NCT00005013?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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