NCT00118833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 26, 2007

Status Verified

September 1, 2007

First QC Date

July 7, 2005

Last Update Submit

September 25, 2007

Conditions

Anxiety DisordersMental Health

Keywords

Social Anxiety DisorderSocial PhobiaGeneralized Anxiety DisorderHypericumSt. John's wortMedicine, HerbalComplementary Therapies

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • Brief Social Phobia Scale (BSPS)

  • Liebowitz Social Anxiety Scale

  • Social Phobia Inventory (SPIN)

  • Self-Rating Depression Scale (SDS)

  • Hospital Anxiety and Depression Scale (HADS)

Interventions

Hypericum perforatum (St. John's wort)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of GSAD
  • Brief Social Phobia Scale (BSPS) score of 20 or higher

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-BeingPhobia, SocialGeneralized Anxiety Disorder

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehaviorPhobic Disorders

Study Officials

  • Wei Zhang, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 12, 2005

Study Start

August 1, 2002

Study Completion

June 1, 2006

Last Updated

September 26, 2007

Record last verified: 2007-09

Locations

US(1)