St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00118833 |
Recruitment Status :
Completed
First Posted : July 12, 2005
Last Update Posted : September 26, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD).
Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety Disorders Mental Health | Drug: Hypericum perforatum (St. John's wort) | Phase 2 Phase 3 |
The use of complementary and alternative medicine (CAM) has grown dramatically over the last decade. Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. Evidence suggests that the botanical St. John's wort has neurochemical activity similar to that of conventional medications. However, research on the safety and effectiveness of St. John's wort is limited. This study will determine the safety and effectiveness of St. John's wort in treating GSAD, a serious condition characterized by intense fear of various social situations that may cause embarrassment.
Participants will be randomly assigned to receive either St. John's wort or placebo daily for 10 weeks. Self-report scales will be used to assess participants' GSAD symptoms at study entry and at study completion. Blood collection will occur at every weekly study visit to determine the levels of St. John's wort in the blood.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD) |
Study Start Date : | August 2002 |
Actual Study Completion Date : | June 2006 |

- Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time
- Brief Social Phobia Scale (BSPS)
- Liebowitz Social Anxiety Scale
- Social Phobia Inventory (SPIN)
- Self-Rating Depression Scale (SDS)
- Hospital Anxiety and Depression Scale (HADS)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of GSAD
- Brief Social Phobia Scale (BSPS) score of 20 or higher
Exclusion Criteria:
- Comorbid anxiety, depressive, or bipolar disorders
- Schizophrenia
- Cognitive impairment
- Substance abuse or dependence within 1 year prior to study entry
- Any unstable medical condition
- Clinically significant laboratory or electrocardiogram (EKG) abnormality
- Currently use psychotropic medications or may need psychotropic medication during the study
- Psychotherapy within 6 weeks prior to study entry
- Failed a previous trial of St. John's wort at doses of 1800 mg/day or greater
- Pregnancy or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118833
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Wei Zhang, MD | Duke University |
ClinicalTrials.gov Identifier: | NCT00118833 |
Other Study ID Numbers: |
K23AT000583-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 12, 2005 Key Record Dates |
Last Update Posted: | September 26, 2007 |
Last Verified: | September 2007 |
Social Anxiety Disorder Social Phobia Generalized Anxiety Disorder Hypericum |
St. John's wort Medicine, Herbal Complementary Therapies |
Disease Anxiety Disorders Phobia, Social |
Pathologic Processes Mental Disorders Phobic Disorders |