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

August 3, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

September 1, 2003

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 3, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT000391-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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