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

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00118833
First received: July 7, 2005
Last updated: September 25, 2007
Last verified: September 2007
  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)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Wei Zhang, MD Duke University
  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 August 20, 2014