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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00118833 |
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 | Intervention | Phase |
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Anxiety Disorders Mental Health |
Drug: Hypericum perforatum (St. John's wort) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD) |
Estimated Enrollment: | 56 |
Study Start Date: | August 2002 |
Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | K23 AT000583-01 |
Study First Received: | July 7, 2005 |
Last Updated: | September 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00118833 History of Changes |
Health Authority: | United States: Federal Government |
Social Anxiety Disorder Social Phobia Generalized Anxiety Disorder Hypericum |
St. John's wort Medicine, Herbal Complementary Therapies |
Anxiety Disorders Mental Disorders Phobic Disorders |
Pathologic Processes Disease Anxiety Disorders Mental Disorders Phobic Disorders |