Depressive Disorder, MajorPhase 2NCT00451516
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
A Phase 2 study testing Herbal medicine (St. John's wort and Kava) in people with Depressive Disorder, Major and Anxiety Disorders, run by The University of Queensland at 1 site in Australia.
Trial summary
SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety commonly occurs, it is conceivable that a combination of an established antidepressant agent such as SJW and an established anxiolytic agent such… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major, Anxiety Disorders
- What is being tested?
- Herbal medicine (St. John's wort and Kava)
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2007to Oct 2007
- 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
- Any person male or female aged 18-65 presenting with a diagnosis of unipolar depression confirmed by CIDI auto (quantified by BDI) and an anxiety score on the DASS of 8 or above i.e. the mean (quantified also by BAI)
Who cannot join
- Psychotic/ Bipolar illness
- Current or < 6 month significant suicidal ideation
- Diagnosed hepato-biliary disease/inflammation
- Current or < 6 month substance abuse disorder including alcohol
- Current or < 12 month use of kava, St. John's wort,
- Current or < 1 month of synthetic antidepressants or benzodiazepines
Show all 18Show fewer
- Previous reaction to kava or St. John's wort
- Medications that maybe pharmacokinetically altered via St. John's wort including:
- Amitriptyline anti-coagulants e.g. phenprocoumon, warfarin,
- Anti-fugals e.g. voriconazole,
- Anti-histamines e.g. fexofenadine,
- Benzodiazepines e.g. alprazolam,
- Chemotherapeutics e.g. irinotecan, digoxin, HIV medication (anti-retrovirals), * Immunosuppressants e.g. cyclosporine, methadone, OCP,
- Statins e.g. simvastatin, warfarin (Henderson 2002; Izzo 2004).
- However this interactions are based on case studies and theoretical interactions and are regarded to be induced by hyperforin (a constituent of St. John's wort); low or non-standardised hyperforin preparations are regarded to not induce drug interactions as little induction of P-glycoprotein and CYP P450 enzymes occurs (Madabushi et al. 2006). Although in vitro studies have confirmed that kava and the isolated kavalactones modulate certain CYP 450 enzymes, no documented evidence of human kava-drug pharmacokinetic interactions exists (Mathews, Etheridge \& Black 2002; Singh 2005)
- Seeing a psychologist or counsellor currently or in the previous month.
- Non-English speakers.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety commonly occurs, it is conceivable that a combination of an established antidepressant agent such as SJW and an established anxiolytic agent such as kava may effectively treat MDD presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid anxiety, than by the individual substances alone. Determination of this is not addressed in this study due to limitations of time and resources. The determination of the strength of the SJW-kava combination will be ascertained by comparing similar trials using SJW and kava mono-therapy in addressing MDD and GAD.
The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid anxiety more than placebo.
- Conditions
- Depressive Disorder, Major, Anxiety Disorders
- Being tested
- Herbal medicine (St. John's wort and Kava)
- Keywords
- Plant, medicine, Psychiatry, Major depressive disorder, Anxiety, Major Depressive Disorder with comorbid anxiety
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicine (St. John's wort and Kava)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI II
BAI
DASS
Secondary outcomes (2)
WHOQOL
Daily Mood Monitoring Form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Investigators
- Jerome Sarris, BHSc, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451516
- Sponsor's protocol ID
- 2006000925
- Status last verified
- May 2008
- First submitted
- 22 Mar 2007
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
- ClinicalTrials.gov ID
- NCT00451516
- Acronym / sponsor ID
- 2006000925
- Conditions
- Depressive Disorder, Major, Anxiety Disorders
- Keywords
- Plant, medicine, Psychiatry, Major depressive disorder, Anxiety, Major Depressive Disorder with comorbid anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Mar 2007 (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.
SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety commonly occurs, it is conceivable that a combination of an established antidepressant agent such as SJW and an established anxiolytic agent such as kava may effectively treat MDD presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid anxiety, than by the individual substances alone. Determination of this is not addressed in this study due to limitations of time and resources. The determination of the strength of the SJW-kava combination will be ascertained by comparing similar trials using SJW and kava mono-therapy in addressing MDD and GAD.
The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid anxiety more than placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 (1 listed)
- Any person male or female aged 18-65 presenting with a diagnosis of unipolar depression confirmed by CIDI auto (quantified by BDI) and an anxiety score on the DASS of 8 or above i.e. the mean (quantified also by BAI)
Key exclusion criteria (18 listed)
- Psychotic/ Bipolar illness
- Current or < 6 month significant suicidal ideation
- Diagnosed hepato-biliary disease/inflammation
- Current or < 6 month substance abuse disorder including alcohol
- Current or < 12 month use of kava, St. John's wort,
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 |
|---|---|---|
| Herbal medicine (St. John's wort and Kava) | Drug | – |
Primary outcome
BDI II
BAI
DASS
2 secondary outcomes
WHOQOL
Daily Mood Monitoring Form
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 19 May 2008.
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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.
Jerome Sarris, BHSc principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herbal medicine (St. John's wort and Kava) in people with Depressive Disorder, Major and Anxiety Disorders, run by The University of Queensland at 1 site in Australia.
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 1 inclusion and 18 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 19 May 2008. 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 Australia. 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.
What does the primary outcome measure?
BDI II. The study lists 3 primary outcomes in all. 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 19 May 2008.