Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005013
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2000-03-31
Brief Title:
Treatment of Major Depression With St Johns Wort Hypericum
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
A Placebo Controlled Clinical Trial of a Standardized Extract of Hypericum Perforatum in Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to study the acute efficacy and safety of a standardized extract of the herb Hypericum perforatum St Johns 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 Johns 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
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 Johns 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
Detailed Description:
This trial will determine the acute antidepressant efficacy of a standardized extract of hypericum St Johns 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT | None | None | None |