St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD)

Conditions
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Anxiety Disorders, Mental Health

Intervention / Treatment
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* Drug: Hypericum perforatum (St. John's wort)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hypericum perforatum (St. John's wort)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Social Phobia Scale (BSPS) |  |  | 
| Liebowitz Social Anxiety Scale |  |  | 
| Social Phobia Inventory (SPIN) |  |  | 
| Self-Rating Depression Scale (SDS) |  |  | 
| Hospital Anxiety and Depression Scale (HADS) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Hypericum, St. John's wort, Medicine, Herbal, Complementary Therapies