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St. John's Wort Versus Placebo in Social Phobia

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00035412
First received: May 3, 2002
Last updated: August 17, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Phobic Disorders
Drug: St. John’s Wort
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: St. John's Wort Versus Placebo in Social Phobia

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 40
Study Start Date: December 2001
Estimated Study Completion Date: August 2004
Detailed Description:

Social Phobia is a prevalent and debilitating condition, with a lifetime prevalence rate to be 13.3 percent. Socially phobic patients have been found to be functionally impaired in the areas of education, employment and social relationships, to have poorer quality of life, and increased suicidal ideation and psychiatric comorbidity. Double-blind studies have found benzodiazepines, selective and non-selective MAOI inhibitors, several SSRIs, and the anticonvulsants pregabalin and gabapentin to be effective. However, side effects with these compounds suggests the need for better tolerated compounds, e.g., in the paroxetine multi-center trial (the only drug with an FDA approved indication), 27 percent reported somnolence, 26 percent nausea, and 37 percent of males reported delayed ejaculation; 34 percent of patients discontinued the trial early. There has been considerable worldwide interest in St. John's Wort (SJW) (Hypericum perforatum) as a treatment of mild to moderate depression. There have been 23 randomized trials suggesting SJW is more effective than placebo for the treatment of outpatients with mild to moderate depression. SJW is very well tolerated with mild side effects observed in only 2.5 percent of cases in a large (3250 patients) drug monitoring study. Pharmacokinetic studies have found Hypericum to have affinity for serotonin, dopamine and GABA alpha and GABA beta receptors, each of which have been implicated in social phobia, thus there is a suggestion that SJW may be effective for this disorder.

This will be a 12-week, double blind, placebo-controlled trial, designed to generate effect size data that will be used to determine sample size needed to power a definitive study. Forty patients will be randomized to either SJW (LI 160) or matching placebo. This will be a flexible-dose design, starting at 300 mg tid to a maximum of 1800 mg total per day. An intent-to-treat analysis will be employed. Subjects will be evaluated weekly for two weeks, then bi-weekly thereafter. The primary outcome measure will be the change from baseline to endpoint on the Liebowitz Social Anxiety Scale.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035412

Locations
United States, Wisconsin
The Dean Foundation for Health, Research, and Education
Madison, Wisconsin, United States, 53562
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth Kobak, PhD Dean Foundation for Health, Research and Analysis
Principal Investigator: Leslie Taylor, MD Dean Foundation for Health, Research and Analysis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00035412     History of Changes
Other Study ID Numbers: R21 AT000502-01A1
Study First Received: May 3, 2002
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Social phobia
Social anxiety
Anxiety
St. John’ Wort
Wisconsin
Psychiatric
Mental health

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014