Back to results

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

Primary Purpose

Anxiety Disorders, Mental Health

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hypericum perforatum (St. John's wort)

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Social Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Hypericum, St. John's wort, Medicine, Herbal, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Outcomes

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)

Full Information

NCT ID

NCT00118833

First Posted

July 7, 2005

Last Updated

September 25, 2007

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00118833

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders, Mental Health

Keywords

Social Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Hypericum, St. John's wort, Medicine, Herbal, Complementary Therapies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Hypericum perforatum (St. John's wort)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Brief Social Phobia Scale (BSPS)

Title

Liebowitz Social Anxiety Scale

Title

Social Phobia Inventory (SPIN)

Title

Self-Rating Depression Scale (SDS)

Title

Hospital Anxiety and Depression Scale (HADS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Zhang, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs