NCT Number: NCT00035438
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Nih
Registry information
Important dates
- Study start
- 2002
- Study completion
- 2003
- First posted
- May 6, 2002
- Registry last updated
- Aug 4, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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