NCT00035438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

August 4, 2006

Status Verified

August 1, 2006

First QC Date

May 3, 2002

Last Update Submit

August 3, 2006

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorderocdAnxietySt. John's WortWisconsinPsychiatricMental health

Interventions

St. John's WortDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73190, United States

Location

Dean Foundation

Madison, Wisconsin, 53562, United States

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive DisorderCompulsive Personality DisorderAnxiety DisordersPsychological Well-Being

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Mental DisordersPersonality DisordersPersonal SatisfactionBehavior

Study Officials

  • Kenneth Kobak, PhD

    Dean Foundation for Health, Research and Analysis

    PRINCIPAL INVESTIGATOR

  • Leslie Taylo, MD

    Dean Foundation for Health, Research and Analysis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 3, 2002

First Posted

May 6, 2002

Study Start

May 1, 2002

Study Completion

September 1, 2003

Last Updated

August 4, 2006

Record last verified: 2006-08

Locations

US(2)