St. John’s Wort Vs. Placebo in Obsessive-Compulsive NCT00035438

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00035438
Other study ID #	R21AT000391-01
Secondary ID
Status	Completed
Phase	Phase 2
First received	May 3, 2002
Last updated	August 3, 2006
Start date	May 2002
Est. completion date	September 2003

Study information
Verified date	August 2006
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	60
Est. completion date	September 2003
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years to 65 Years
Eligibility	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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• St. John’s Wort

Locations
Country	Name	City	State
United States	Dean Foundation	Madison	Wisconsin
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma

Sponsors *(1)*
Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,

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Completed	`NCT02421315` - Overlapping Neural Circuits in Pediatric OCD	N/A
Completed	`NCT01981317` - Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder	N/A
Completed	`NCT02194075` - Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder	Phase 4
Completed	`NCT01686087` - Attaining and Maintaining Wellness in Obsessive-compulsive Disorder	N/A
Completed	`NCT01331876` - Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy	N/A
Terminated	`NCT00997087` - A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder	Phase 2
Completed	`NCT00533806` - Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder	Phase 3
Completed	`NCT00517244` - Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders	N/A
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External Links

A non-profit foundation located in Middleton, Wisconsin, conducting clinical trials of psychiatric and medical therapies.

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

Clinical Trial Details — Status: Completed

Administrative data

Study information