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

Tracking Information

First Received Date ^ICMJE

May 3, 2002

Last Updated Date

August 3, 2006

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00035438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Drug: St. John’s Wort

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00035438

Responsible Party

Study ID Numbers ^ICMJE

R21 AT000391-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

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