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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypericum perforatum (St. John's wort) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Social Phobia Scale (BSPS) | ||
| Liebowitz Social Anxiety Scale | ||
| Social Phobia Inventory (SPIN) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D000072861 | Phobia, Social |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| C422326 | Hypericum extract LI 160 |
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| Self-Rating Depression Scale (SDS) |
| Hospital Anxiety and Depression Scale (HADS) |