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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118833
• Other study ID #: K23AT000583-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2005
• Last updated: September 25, 2007
• Start date: August 2002
• Est. completion date: June 2006

Study information

• Verified date: September 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Mental Health
• Phobic Disorders

Intervention

Drug:
• Hypericum perforatum (St. John's wort)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time
Secondary	Brief Social Phobia Scale (BSPS)
Secondary	Liebowitz Social Anxiety Scale
Secondary	Social Phobia Inventory (SPIN)
Secondary	Self-Rating Depression Scale (SDS)
Secondary	Hospital Anxiety and Depression Scale (HADS)