Anxiety DisordersPhase 2NCT00083980
Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
A Phase 2 study testing Venlafaxine ER, Sugar pill and Kava in people with Anxiety Disorders, run by National Center for Complementary and Integrative Health (NCCIH).
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Venlafaxine ER, Sugar pill and Kava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Aug 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of generalized anxiety disorder (GAD)
Who cannot join
None listed.
About this study
Official title: KAVA KAVA in Generalized Anxiety: A Double-Blind Trial
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).
Read the detailed description
Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.
This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.
- Conditions
- Anxiety Disorders
- Being tested
- Venlafaxine ER, Sugar pill, Kava
- Keywords
- Kava, Complementary Therapies, Medicine, Herbal
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine ERDrug
Also called Effexor XR
75 to 225 mg daily
Sugar pillDrug
Also called No brand name
Upto 3 per day for venlafainxe and 4 per day for kava placebos.
KavaDrug
Also called No brand name
140 to 280 mg per day
| Study group | Role | What they receive |
|---|---|---|
| active antidepressant drug comparator | Active comparator | Venlafaxine ER Receives: Drug: Venlafaxine ER; Drug: Sugar pill |
| Sugar pill | Placebo comparator | Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine Receives: Drug: Sugar pill |
| Herbal treatment kava | Experimental | Kava Receives: Drug: Sugar pill; Drug: Kava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2004 (estimated)
- Study startJun 2002
- Primary completionJun 2004
- Study completionAug 2004
Why it stopped: European reports of liver toxicity from kava meant that the study had to stop
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jonathan Davidson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083980
- Sponsor's protocol ID
- R01AT000150-01A1
- Status last verified
- Aug 2006
- First submitted
- 4 Jun 2004
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KAVA KAVA in Generalized Anxiety: A Double-Blind Trial
- ClinicalTrials.gov ID
- NCT00083980
- Acronym / sponsor ID
- R01AT000150-01A1
- Conditions
- Anxiety Disorders
- Keywords
- Kava, Complementary Therapies, Medicine, Herbal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: European reports of liver toxicity from kava meant that the study had to stop
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 7 Jun 2004 (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 evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).
Detailed description
Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.
This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active antidepressant drug comparator | Active comparator | Drug: Venlafaxine ER, Drug: Sugar pillVenlafaxine ER |
| Sugar pill | Placebo comparator | Drug: Sugar pillInert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine |
| Herbal treatment kava | Experimental | Drug: Sugar pill, Drug: KavaKava |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of generalized anxiety disorder (GAD)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Venlafaxine ERAlso: Effexor XR75 to 225 mg daily | Drug | active antidepressant drug comparator |
| Sugar pillAlso: No brand nameUpto 3 per day for venlafainxe and 4 per day for kava placebos. | Drug | Herbal treatment kava, Sugar pill, active antidepressant drug comparator |
| KavaAlso: No brand name140 to 280 mg per day | Drug | Herbal treatment kava |
Primary outcome
Hamilton Anxiety Scale
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: European reports of liver toxicity from kava meant that the study had to stop). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
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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.
Jonathan Davidson, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venlafaxine ER, Sugar pill and Kava in people with Anxiety Disorders, run by National Center for Complementary and Integrative Health (NCCIH).
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 0 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: stopped early, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was stopped early (reason given: European reports of liver toxicity from kava meant that the study had to stop). Results are not available in the source record.
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?
Hamilton Anxiety Scale (time frame: 8 weeks). 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 Oct 2012.