|
Treatment of Major Depression with St. John's Wort (Hypericum) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Treatment of Major Depression with St. John's Wort (Hypericum) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of Major Depression with St. John's Wort (Hypericum) Clinical research trials and Treatment of Major Depression with St. John's Wort (Hypericum) health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Treatment of Major Depression with St. John's Wort (Hypericum). Treatment of Major Depression with St. John's Wort (Hypericum) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Treatment of Major Depression with St. John's Wort (Hypericum) clinical trial. Human subjects frequently get the finest healthcare available for their Treatment of Major Depression with St. John's Wort (Hypericum) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Major Depression with St. John's Wort (Hypericum)  Treatment of Major Depression with St. John's Wort (Hypericum)
Treatment of Major Depression with St. John's Wort (Hypericum)
For Condition: Major Depression
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) , National Center for Complementary and Alternative Medicine (NCCAM)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Inclusion Criteria: 1. Major depression assessed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID; First et al, 1995); 2. Minimum score greater than or equal to 20 on the 17-item Hamilton Depression (HAM-D) Scale at screen and at baseline; 3. GAF of 60 or less (moderate symptoms) at screen and at baseline; 4. HAM-D cannot decrease by 25% or more between screening and baseline; 5. Capacity to give informed consent and to follow study procedures. - Not breast-feeding - Abstinence or effective method of birth control / contraception including oral contraceptives during the study - Not pregnant Exclusion Criteria: Exclusion Criteria: 1. Higher than "2" on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk. 2. Women of childbearing age who are pregnant, planning pregnancy in the next 6 months, breast-feeding, or not using medically acceptable means of birth control (hormonal treatment such as birth control pill, injection or implant, IUD, or double barrier of condom and diaphragm together is acceptable; primary use of condom, sponge or diaphragm alone (single barrier) is not acceptable because these may carry a higher rate of failure when used alone. 3. Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal; asymptomatic Gilbert's syndrome is not an exclusion). 4. Serious or unstable medical illness. 5. History of seizure disorder (other than febrile). 6. Any of the following DSM-IV diagnoses by SCID: a) current (within past 6 months) alcohol or other substance abuse disorder; b) schizophrenia, schizo-affective, or other psychotic disorder; c) bipolar disorder; d) current panic disorder or obsessive compulsive disorder; e) history of psychotic features of affective disorder (mood congruent or incongruent). 7. Clinical or laboratory evidence of untreated or unstable thyroid disorder. 8. Patients who have failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent. 9. Patients who, during this current episode of depression, have taken sertraline or any form of hypericum, at any dose level, daily, for at least one month, within the past 6 months. 10. Current (within past 6 months) use of other prescription or non-prescription drugs, including anticonvulsants and other medications with significant psychotropic properties, antiretroviral medications, cyclosporine, digoxin, coumadin, dietary supplements, natural remedies, and botanical preparations (eg, hypericum, kava, valerian). 11. Patients who have had other investigational drugs within 30 days or other psychotropic medication within 21 days of baseline (6 weeks for fluoxetine). 12. Patients with a known allergy or hypersensitivity to the study medications. 13. Positive drug urine screen. 14. Patients who have been in psychotherapy for 2 months or less at the time of enrollment into the study. Patients who are receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period. 15. Patients with mental retardation or cognitive impairment, or any disorder that might interfere with their ability to consent or follow study procedures and requirements.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanDavidson, Principal Investigator, Duke Univ Med Ctr
Seattle Clinical Research Center
Seattle, Washington, 98104
United States
Dean Foundation for Hlth Rsch and Education
Middleton, Wisconsin, 53562
United States
Emory Mood and Anxiety Disorders Clinical Trials Program
Atlanta, Georgia, 30329
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Eastside Comprehensive Medical Services
New York City, New York, 10021
United States
Univ of South Florida College of Med
Tampa, Florida, 33613
United States
Harbor-UCLA Rsch and Education Inst
Torrance, California, 90502
United States
Feighner Research Institute
San Diego, California, 92121
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
United States
Univ of Cincinnati Medical Ctr
Cincinnati, Ohio, 45267
United States
McLean Hospital
Belmont, Massachusetts, 02478
United States
Additional Information:
Study ID Numbers: N01-MH-70007A;
Study Start Date: December 1998
Record last reviewed: July 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005013
Other Major Depression Studies:
1. Treatment of Major Depression with St. John's Wort (Hypericum)
Related Studies:
Other Major Depression Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Treatment of Major Depression with St. John's Wort (Hypericum)
|
|
|
|
|
|
|
|
