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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Anxiety Disorders

Mental Health

Treatments

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

Study type

Interventional

Funder types

NIH

Identifiers

NCT00118833

K23AT000583-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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