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

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00118833

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 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)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Mental Health Phobias

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time

Secondary Outcome Measures:

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

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118833

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Wei Zhang, MD

Duke University

More Information

No publications provided

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

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

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Phobic Disorders
St. John's Wort

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Phobic Disorders

ClinicalTrials.gov processed this record on September 09, 2009