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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00035438. Last updated on August 3, 2006. Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Obsessive Compulsive Disorder

Intervention ^†

Drug: St. John’s Wort

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

May 2002

Completion Date

September 2003

Eligibility 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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00035438

Organization ID

R21 AT000391-01

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

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

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

May 3, 2002

Last Updated Date

August 3, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.