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

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00035438

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: St. John's Wort	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Study Completion Date :

Sep 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma	United States	73190
2	Dean Foundation	Madison	Wisconsin	United States	53562

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

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