Generalized Anxiety DisorderPhase 4KGADNCT02219880
Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
A Phase 4 study testing Kava (240mg of kavalactones per day) in people with Generalized Anxiety Disorder, run by University of Melbourne at 2 sites in Australia.
Trial summary
The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Kava (240mg of kavalactones per day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 2 sitesAustralia
- Study dates
- 13 Oct 2015to 31 May 2018
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
To be considered for inclusion in this study, participants will be required to meet the following criteria:
- Aged between 18-70 years
- Meets the Diagnostic and Statistical Manual (DSM) IV and DSM-V diagnostic criteria for generalised anxiety disorder (GAD) based on structured interview (Mini International Neuropsychiatric Interview-Plus 6 [MINI-Plus 6]. Note that while the MINI-Plus 6 uses the DSM-IV criteria, the same criteria are used in the DSM-V).
- Presents with anxiety (Hamilton Anxiety Rating Scale ≥ 18) at the time of study entry
- Fluent in written and spoken English
- Provides a signed copy of the consent form
Participants are ineligible to enter the trial if they have any of the following conditions:
- Primary diagnosis other than GAD
- Presentation of moderate to severe depressive symptoms (Montgomery-Asberg Rating Scale: MADRS ≥ 18 at time of study entry or ≥ 24 at any time during study)
- Presentation of suicidal ideation (≥ 3 on MADRS suicidal thoughts domain at time of study entry or at any time during study)
- Current diagnosis of bipolar disorder or schizophrenia on structured interview (MINI Plus)
- Current substance/alcohol use disorder on structured interview (MINI Plus) Page 21 of 39 Commercial-in-Confidence
- Currently taking an antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin or thyroxin, or current regular use (more than 2 days per week) of a benzodiazepine or opioid-based analgesic
- Current use of a psychotropic nutraceutical (e.g. St John's wort)
- Previous intolerance to kava
- Three or more failed trials of pharmacotherapy for the current GAD episode
- Recently commenced psychotherapy (within four weeks of study entry)
- Known or suspected clinically unstable systemic medical disorder
- Diagnosed hepato-biliary disease/inflammation
- Elevated liver enzymes at baseline blood test
- Pregnancy or breastfeeding, or trying to conceive
- Not using medically approved contraception (including abstinence) if female and of childbearing age
- Unable to participate in all scheduled visits, treatment plan, or other trial procedures according to the protocol (except for the optional genetic component)
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4006
Centre for Human Psychopharmacology - Swinburne University
Melbourne, Victoria, 3122
About this study
The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.
Read the detailed description
The primary aim is to confirm the efficacy and safety of Kava compared to placebo in Generalized Anxiety Disorder (GAD). Secondary aims of the study are to confirm the relationship between specific genetic variations and response to Kava, and to explore the effects of Kava on the expression of specific genes.
Consenting participants will be randomly allocated to take either Kava or placebo over 18 weeks. They will be assessed at regular interviews throughout the trial and will have four blood tests (liver function tests to monitor participant safety, and collection of genetic material providing information on neurochemistry). The design of the study is a multi-centre, 18-week, 2-arm, double-blind randomised clinical trial (RCT) using a standardised pharmaceutical-grade water-soluble extract of Kava (240mg of kavalactones per day) versus placebo in 210 adults with GAD.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Kava (240mg of kavalactones per day), Placebo
- Keywords
- Kava, Anxiety, Generalized Anxiety Disorder, Psychiatric, Anxiolytic, GABA, Kavalactones
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kava (240mg of kavalactones per day)Dietary supplement
Also called Kava, Kavalactones, Piper methysticum
Kava 60 milligrams per tablet = 240mg of kavalactones per day
PlaceboDietary supplement
Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Inert tablets matched for colour, size and consistency to active arm treatment. Both treatment arm tablets will match in appearance, and neither participants nor the trial clinicians will know what they are taking. Receives: Dietary Supplement: Placebo |
| Kava - standardised 240mg kavalactones | Experimental | Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day Receives: Dietary Supplement: Kava (240mg of kavalactones per day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAMA) - change in score
Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.
Measured: 18 weeks
Secondary outcomes (1)
Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention
Will assess whether response to Kava will be moderated by gamma-aminobutyric acid (GABA) transporter polymorphisms. Specifically, whether rs2601126-T allele or rs2697153-A allele carriers have greater reduction of anxiety
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study start13 Oct 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Swinburne University of Technology, The University of Queensland
- Responsible party
- Principal investigator, Jerome Sarris, University of Melbourne
- Investigators
- Jerome Sarris, PhD, Principal investigator, The University of Melbourne and The Melbourne Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219880
- Sponsor's protocol ID
- 137/14
- Acronym
- KGAD
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Savage K, Sarris J, Hughes M, Bousman CA, Rossell S, Scholey A, Stough C, Suo C. Neuroimaging Insights: Kava's (Piper methysticum) Effect on Dorsal Anterior Cingulate Cortex GABA in Generalized Anxiety Disorder. Nutrients. 2023 Oct 28;15(21):4586. doi: 10.3390/nu15214586.
PubMed 37960239Sarris J, Byrne GJ, Bousman CA, Cribb L, Savage KM, Holmes O, Murphy J, Macdonald P, Short A, Nazareth S, Jennings E, Thomas SR, Ogden E, Chamoli S, Scholey A, Stough C. Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study. Aust N Z J Psychiatry. 2020 Mar;54(3):288-297. doi: 10.1177/0004867419891246. Epub 2019 Dec 8.
PubMed 31813230Savage KM, Stough CK, Byrne GJ, Scholey A, Bousman C, Murphy J, Macdonald P, Suo C, Hughes M, Thomas S, Teschke R, Xing C, Sarris J. Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial. Trials. 2015 Nov 2;16:493. doi: 10.1186/s13063-015-0986-5.
PubMed 26527536
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02219880
- Acronym / sponsor ID
- KGAD / 137/14
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Kava, Anxiety, Generalized Anxiety Disorder, Psychiatric, Anxiolytic, GABA, Kavalactones
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Swinburne University of Technology, The University of Queensland
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 19 Aug 2014 (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 use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.
Detailed description
The primary aim is to confirm the efficacy and safety of Kava compared to placebo in Generalized Anxiety Disorder (GAD). Secondary aims of the study are to confirm the relationship between specific genetic variations and response to Kava, and to explore the effects of Kava on the expression of specific genes.
Consenting participants will be randomly allocated to take either Kava or placebo over 18 weeks. They will be assessed at regular interviews throughout the trial and will have four blood tests (liver function tests to monitor participant safety, and collection of genetic material providing information on neurochemistry). The design of the study is a multi-centre, 18-week, 2-arm, double-blind randomised clinical trial (RCT) using a standardised pharmaceutical-grade water-soluble extract of Kava (240mg of kavalactones per day) versus placebo in 210 adults with GAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInert tablets matched for colour, size and consistency to active arm treatment. Both treatment arm tablets will match in appearance, and neither participants nor the trial clinicians will know what they are taking. |
| Kava - standardised 240mg kavalactones | Experimental | Dietary Supplement: Kava (240mg of kavalactones per day)Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Kava (240mg of kavalactones per day)Also: Kava, Kavalactones, Piper methysticumKava 60 milligrams per tablet = 240mg of kavalactones per day | Dietary supplement | Kava - standardised 240mg kavalactones |
| PlaceboInert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment. | Dietary supplement | Placebo |
Primary outcome
Hamilton Anxiety Rating Scale (HAMA) - change in score
Time frame: 18 weeks
Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.
1 secondary outcome
Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention
Time frame: 18 weeks
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 15 Oct 2018.
- Derived from this study: PubMed 37960239Savage K, Sarris J, Hughes M, Bousman CA, Rossell S, Scholey A, Stough C, Suo C. Neuroimaging Insights: Kava's (Piper methysticum) Effect on Dorsal Anterior Cingulate Cortex GABA in Generalized Anxiety Disorder. Nutrients. 2023 Oct 28;15(21):4586. doi: 10.3390/nu15214586.
- Derived from this study: PubMed 31813230Sarris J, Byrne GJ, Bousman CA, Cribb L, Savage KM, Holmes O, Murphy J, Macdonald P, Short A, Nazareth S, Jennings E, Thomas SR, Ogden E, Chamoli S, Scholey A, Stough C. Kava for generalised anxiety disorder: A 16-week double-blind, randomised, placebo-controlled study. Aust N Z J Psychiatry. 2020 Mar;54(3):288-297. doi: 10.1177/0004867419891246. Epub 2019 Dec 8.
- Derived from this study: PubMed 26527536Savage KM, Stough CK, Byrne GJ, Scholey A, Bousman C, Murphy J, Macdonald P, Suo C, Hughes M, Thomas S, Teschke R, Xing C, Sarris J. Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial. Trials. 2015 Nov 2;16:493. doi: 10.1186/s13063-015-0986-5.
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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, PhD principal investigator
The University of Melbourne and The Melbourne Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kava (240mg of kavalactones per day) in people with Generalized Anxiety Disorder, run by University of Melbourne at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Oct 2018. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hamilton Anxiety Rating Scale (HAMA) - change in score (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219880, which also lists 3 linked publications.
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 15 Oct 2018.