Obsessive Compulsive DisorderPhase 2NCT00035438
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
A Phase 2 study testing St. John's Wort in people with Obsessive Compulsive Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- St. John's Wort
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2002to Sep 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dean Foundation
Madison, Wisconsin, 53562
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73190
About this study
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.
Read the 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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- St. John's Wort
- Keywords
- obsessive compulsive disorder, ocd, Anxiety, St. John's Wort, Wisconsin, Psychiatric, Mental health
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Personality Disorder, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's WortDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startMay 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenneth Kobak, PhD, Principal investigator, Dean Foundation for Health, Research and AnalysisLeslie Taylo, MD, Principal investigator, Dean Foundation for Health, Research and Analysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035438
- Sponsor's protocol ID
- R21AT000391-01
- Status last verified
- Aug 2006
- First submitted
- 3 May 2002
- Last updated
- 4 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
- ClinicalTrials.gov ID
- NCT00035438
- Acronym / sponsor ID
- R21AT000391-01
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- obsessive compulsive disorder, ocd, Anxiety, St. John's Wort, Wisconsin, Psychiatric, Mental health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- May 2002
- Study completion
- Sep 2003
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| St. John's Wort | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2006.
- A non-profit foundation located in Middleton, Wisconsin, conducting clinical trials of psychiatric and medical therapies.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Kobak, PhD principal investigator
Dean Foundation for Health, Research and Analysis
Leslie Taylo, MD principal investigator
Dean Foundation for Health, Research and Analysis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing St. John's Wort in people with Obsessive Compulsive Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2006.