St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
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Purpose
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 |
|---|---|---|
|
Anxiety Disorders Mental Health |
Drug: Hypericum perforatum (St. John's wort) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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)
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00118833 History of Changes |
| Other Study ID Numbers: | K23 AT000583-01 |
| Study First Received: | July 7, 2005 |
| Last Updated: | September 25, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Social Anxiety Disorder Social Phobia Generalized Anxiety Disorder Hypericum |
St. John's wort Medicine, Herbal Complementary Therapies |
Additional relevant MeSH terms:
|
Anxiety Disorders Phobic Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013