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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118833
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time

Secondary Outcome Measures :
  1. Brief Social Phobia Scale (BSPS)
  2. Liebowitz Social Anxiety Scale
  3. Social Phobia Inventory (SPIN)
  4. Self-Rating Depression Scale (SDS)
  5. Hospital Anxiety and Depression Scale (HADS)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118833


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Wei Zhang, MD Duke University
More Information
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ClinicalTrials.gov Identifier: NCT00118833    
Other Study ID Numbers: K23AT000583-01 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Social Anxiety Disorder
Social Phobia
Generalized Anxiety Disorder
Hypericum
 St. John's wort
Medicine, Herbal
Complementary Therapies
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Phobia, Social
 Pathologic Processes
Mental Disorders
Phobic Disorders