St. John's Wort Vs. Placebo in Obsessive-Compulsive Disor... | NCT00035438

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

NCT00035438

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Aug 4, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Obsessive Compulsive Disorder

Interventions

St. John's Wort

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Sep 2003

First Submitted Date

May 3, 2002

First Submission Date that Met QC Criteria

May 3, 2002

First Posted Date

May 6, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2006

Last Update Posted Date

Aug 4, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
St. John's Wort	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Kobak, PhD	Dean Foundation for Health, Research and Analysis	Principal Investigator
Leslie Taylo, MD	Dean Foundation for Health, Research and Analysis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma Health Science Center		Oklahoma City	Oklahoma	73190	United States
Dean Foundation

References Module

Citations

Not provided

ID	Term
D009771	Obsessive-Compulsive Disorder
D003193	Compulsive Personality Disorder
D001008	Anxiety Disorders
D000092862	Psychological Well-Being

ID	Term
D001523	Mental Disorders
D010554	Personality Disorders
D010549	Personal Satisfaction
D001519	Behavior