Clinical trial NCT00118833: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anxiety Disorders
Mental Health
Keywords: Social Anxiety Disorder
Social Phobia
Generalized Anxiety Disorder
Hypericum
St. John's wort
Medicine, Herbal
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-07-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time
Secondary outcomes:
measure: Brief Social Phobia Scale (BSPS)
measure: Liebowitz Social Anxiety Scale
measure: Social Phobia Inventory (SPIN)
measure: Self-Rating Depression Scale (SDS)
measure: Hospital Anxiety and Depression Scale (HADS)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: