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St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder.

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00035438
First received: May 3, 2002
Last updated: August 3, 2006
Last verified: August 2006

May 3, 2002
August 3, 2006
May 2002
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Complete list of historical versions of study NCT00035438 on ClinicalTrials.gov Archive Site
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St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder.
St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder.

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 obsessive compulsive disorder.

The objective of the proposed study is to assess the efficacy of the herbal St. John’s Wort (SJW) in the treatment of symptoms of obsessive-compulsive disorder (OCD). The approach is to conduct a 12-week, randomized, double blind, placebo controlled, parallel group pilot trial with 30 subjects in each of two arms. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) will be the primary measure for evaluating OCD. An intention-to-treat analysis will be done to compare the two arms.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Obsessive Compulsive Disorder
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
60
September 2003
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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 obsessive compulsive disorder

Exclusion criteria

  • Primary diagnosis of major depression, dysthymia, panic disorder, social phobia, 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 5 weeks of first visit.
  • Failure to respond to at least two adequate antidepressant trials for obsessive compulsive disorder
  • Investigational drugs within 30 days of baseline
  • Known allergy or hypersensitivity to St. John’s Wort
  • Currently in behavior therapy for obsessive compulsive disorder

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
 
NCT00035438
R21 AT000391-01
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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 Taylo, MD Dean Foundation for Health, Research and Analysis
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

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