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

May 3, 2002
August 17, 2006
December 2001
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Complete list of historical versions of study NCT00035412 on ClinicalTrials.gov Archive Site
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St. John's Wort Versus Placebo in Social Phobia
St. John's Wort Versus Placebo in Social Phobia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Phobic Disorders
Drug: St. John’s Wort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2004
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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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035412
R21 AT000502-01A1
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National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Kenneth Kobak, PhD Dean Foundation for Health, Research and Analysis
Principal Investigator: Leslie Taylor, MD Dean Foundation for Health, Research and Analysis
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP