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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-09-30

Brief Summary

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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

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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.

Conditions

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Obsessive Compulsive Disorder

Keywords

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obsessive compulsive disorder ocd Anxiety St. John's Wort Wisconsin Psychiatric Mental health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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St. John's Wort

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kenneth Kobak, PhD

Role: PRINCIPAL_INVESTIGATOR

Dean Foundation for Health, Research and Analysis

Leslie Taylo, MD

Role: PRINCIPAL_INVESTIGATOR

Dean Foundation for Health, Research and Analysis

Locations

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University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Dean Foundation

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT000391-01

Identifier Type: NIH

Identifier Source: org_study_id

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