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Completed

NCT Number: NCT00118833

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

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.

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Key information

Conditions

Anxiety Disorders Behavior Generalized Anxiety Disorder Mental Disorders Mental Health Personal Satisfaction Phobia, Social Phobic Disorders Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypericum perforatum (St. John's wort)

Drug

Primary outcomes

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

Secondary outcomes

  1. Brief Social Phobia Scale (BSPS)

  2. Liebowitz Social Anxiety Scale

  3. Social Phobia Inventory (SPIN)

  4. Self-Rating Depression Scale (SDS)

  5. Hospital Anxiety and Depression Scale (HADS)

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Jul 12, 2005
Registry last updated
Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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