St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: St. John’s Wort |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | St. John’s Wort Vs. Placebo in Obsessive-Compulsive Disorder. |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | September 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Oklahoma | |
| University of Oklahoma Health Science Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Wisconsin | |
| Dean Foundation | |
| Madison, Wisconsin, United States, 53562 | |
| Principal Investigator: | Kenneth Kobak, PhD | Dean Foundation for Health, Research and Analysis |
| Principal Investigator: | Leslie Taylo, MD | Dean Foundation for Health, Research and Analysis |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00035438 History of Changes |
| Other Study ID Numbers: | R21 AT000391-01 |
| Study First Received: | May 3, 2002 |
| Last Updated: | August 3, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
obsessive compulsive disorder ocd Anxiety St. John’s Wort |
Wisconsin Psychiatric Mental health |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013