Trial record 7 of 50 for:    Obsessive Compulsive Disorder [CONDITION] AND NIH [SPONSOR-COLLABORATORS-CLASS] NOT NIMH [ORGANIZATION-NAME]

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
  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 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 Vs. Placebo in Obsessive-Compulsive Disorder.

Resource links provided by NLM:


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
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: 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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00035438     History of Changes
Other Study ID Numbers: R21 AT000391-01
Study First Received: May 3, 2002
Last Updated: August 3, 2006
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

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 21, 2014