Anxiety DisordersPhase 2/3NCT00118833
St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)
A Phase 2/3 study testing Hypericum perforatum (St. John's wort) in people with Anxiety Disorders and Mental Health, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD). Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Mental Health
- What is being tested?
- Hypericum perforatum (St. John's wort)
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2006
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of GSAD
- Brief Social Phobia Scale (BSPS) score of 20 or higher
Who cannot join
- Comorbid anxiety, depressive, or bipolar disorders
- Schizophrenia
- Cognitive impairment
- Substance abuse or dependence within 1 year prior to study entry
- Any unstable medical condition
- Clinically significant laboratory or electrocardiogram (EKG) abnormality
Show all 10Show fewer
- Currently use psychotropic medications or may need psychotropic medication during the study
- Psychotherapy within 6 weeks prior to study entry
- Failed a previous trial of St. John's wort at doses of 1800 mg/day or greater
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD)
This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD).
Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.
Read the detailed description
The use of complementary and alternative medicine (CAM) has grown dramatically over the last decade. Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. Evidence suggests that the botanical St. John's wort has neurochemical activity similar to that of conventional medications. However, research on the safety and effectiveness of St. John's wort is limited. This study will determine the safety and effectiveness of St. John's wort in treating GSAD, a serious condition characterized by intense fear of various social situations that may cause embarrassment.
Participants will be randomly assigned to receive either St. John's wort or placebo daily for 10 weeks. Self-report scales will be used to assess participants' GSAD symptoms at study entry and at study completion. Blood collection will occur at every weekly study visit to determine the levels of St. John's wort in the blood.
- Conditions
- Anxiety Disorders, Mental Health
- Being tested
- Hypericum perforatum (St. John's wort)
- Keywords
- Social Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Hypericum, St. John's wort, Medicine, Herbal, Complementary Therapies
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Phobia, Social, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypericum perforatum (St. John's wort)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time
Secondary outcomes (5)
Brief Social Phobia Scale (BSPS)
Liebowitz Social Anxiety Scale
Social Phobia Inventory (SPIN)
Self-Rating Depression Scale (SDS)
Hospital Anxiety and Depression Scale (HADS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startAug 2002
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Wei Zhang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118833
- Sponsor's protocol ID
- K23AT000583-01
- Status last verified
- Sep 2007
- First submitted
- 7 Jul 2005
- Last updated
- 26 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Trial of Hypericum Perforatum in the Treatment of Generalized Social Anxiety Disorder (GSAD)
- ClinicalTrials.gov ID
- NCT00118833
- Acronym / sponsor ID
- K23AT000583-01
- Conditions
- Anxiety Disorders, Mental Health
- Keywords
- Social Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Hypericum, St. John's wort, Medicine, Herbal, Complementary Therapies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2002
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Jul 2005 (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.
This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD).
Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.
Detailed description
The use of complementary and alternative medicine (CAM) has grown dramatically over the last decade. Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. Evidence suggests that the botanical St. John's wort has neurochemical activity similar to that of conventional medications. However, research on the safety and effectiveness of St. John's wort is limited. This study will determine the safety and effectiveness of St. John's wort in treating GSAD, a serious condition characterized by intense fear of various social situations that may cause embarrassment.
Participants will be randomly assigned to receive either St. John's wort or placebo daily for 10 weeks. Self-report scales will be used to assess participants' GSAD symptoms at study entry and at study completion. Blood collection will occur at every weekly study visit to determine the levels of St. John's wort in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of GSAD
- Brief Social Phobia Scale (BSPS) score of 20 or higher
Key exclusion criteria (10 listed)
- Comorbid anxiety, depressive, or bipolar disorders
- Schizophrenia
- Cognitive impairment
- Substance abuse or dependence within 1 year prior to study entry
- Any unstable medical condition
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 |
|---|---|---|
| Hypericum perforatum (St. John's wort) | Drug | – |
Primary outcome
Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time
5 secondary outcomes
Brief Social Phobia Scale (BSPS)
Liebowitz Social Anxiety Scale
Social Phobia Inventory (SPIN)
Self-Rating Depression Scale (SDS)
Hospital Anxiety and Depression Scale (HADS)
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 26 Sep 2007.
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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.
Wei Zhang, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hypericum perforatum (St. John's wort) in people with Anxiety Disorders and Mental Health, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site 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 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Clinical Global Impression (CGI), designed to assess global severity of illness and change in the clinical condition over time. It is what the study was designed to measure, not a finding.
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 26 Sep 2007.