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

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
St. John's Wort
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring obsessive compulsive disorder, ocd, Anxiety, St. John's Wort, Wisconsin, Psychiatric, Mental health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Science Center
  • Dean Foundation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 3, 2002
Last Updated
August 3, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00035438
Brief Title
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
Official Title
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
obsessive compulsive disorder, ocd, Anxiety, St. John's Wort, Wisconsin, Psychiatric, Mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
St. John's Wort

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Kobak, PhD
Organizational Affiliation
Dean Foundation for Health, Research and Analysis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie Taylo, MD
Organizational Affiliation
Dean Foundation for Health, Research and Analysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Dean Foundation
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.dean.org
Description
A non-profit foundation located in Middleton, Wisconsin, conducting clinical trials of psychiatric and medical therapies.

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

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