NCT00035412

Brief Summary

The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with social phobia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2001

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

May 3, 2002

Last Update Submit

August 17, 2006

Conditions

Phobic Disorders

Keywords

Social phobiaSocial anxietyAnxietySt. John' WortWisconsinPsychiatricMental health

Interventions

St. John's WortDRUG

Eligibility Criteria

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

You may qualify if:

  • Female patients: at least 2 years post-menopausal, surgically sterile, or practicing a medically acceptable method of contraception.
  • Meets DSM-IV criteria for Social Phobia, generalized subtype, lasting 12 months in duration (phone screening will determine)

You may not qualify if:

  • Primary diagnosis of major depression, dysthymia, panic disorder, schizophrenia, schizo-affective disorder, bipolar disorder, or PTSD
  • Substance abuse or dependence in the past 6 months
  • Vascular dementia or primary degenerative dementia of the Alzheimer's type
  • Treatment with MAOIs, TCAs, SSRIs, venlafaxine, nefazodone, remeron, citalopram, or bupropion within 14 days of first visit.
  • Fluoxetine within 14 days of first visit.
  • Failure to respond to at least two adequate antidepressant trials for social anxiety.
  • Investigational drugs within 30 days of baseline
  • Known allergy or hypersensitivity to St. John's Wort
  • Currently in behavior therapy for Social Phobia
  • ALL INQUIRIES WILL UNDERGO A PHONE SCREENING TO DETERMINE WHETHER THEY MEET ELIGIBLITY REQUIREMENTS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Dean Foundation for Health, Research, and Education

Madison, Wisconsin, 53562, United States

Location

Related Links

MeSH Terms

Conditions

Phobic DisordersPhobia, SocialAnxiety DisordersPsychological Well-Being

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Kenneth Kobak, PhD

    Dean Foundation for Health, Research and Analysis

    PRINCIPAL INVESTIGATOR

  • Leslie Taylor, MD

    Dean Foundation for Health, Research and Analysis

    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

May 3, 2002

First Posted

May 6, 2002

Study Start

December 1, 2001

Study Completion

August 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(1)