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

This study has been completed.

First Received: May 3, 2002 Last Updated: August 3, 2006 History of Changes

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00035438

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 obsessive compulsive disorder.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: St. John’s Wort	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

U.S. FDA Resources

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

Estimated Enrollment:	60
Study Start Date:	May 2002
Estimated Study Completion Date:	September 2003

Detailed Description:

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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035438

Locations

United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73190
United States, Wisconsin
Dean Foundation
Madison, Wisconsin, United States, 53562

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	Kenneth Kobak, PhD	Dean Foundation for Health, Research and Analysis
Principal Investigator:	Leslie Taylo, MD	Dean Foundation for Health, Research and Analysis

More Information

Additional Information:

A non-profit foundation located in Middleton, Wisconsin, conducting clinical trials of psychiatric and medical therapies. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	R21 AT000391-01
Study First Received:	May 3, 2002
Last Updated:	August 3, 2006
ClinicalTrials.gov Identifier:	NCT00035438 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

obsessive compulsive disorder
ocd
Anxiety
St. John’s Wort

Wisconsin
Psychiatric
Mental health

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
St. John's Wort
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on September 11, 2009