St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
|ClinicalTrials.gov Identifier: NCT00118833|
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : September 26, 2007
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|
|Intervention Model:||Parallel Assignment|
|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)
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|