St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
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.
Drug: Hypericum perforatum (St. John's wort)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD)|
- 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)
|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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Wei Zhang, MD||Duke University|