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| Name | Class |
|---|---|
| Swinburne University of Technology | OTHER |
| The University of Queensland | OTHER |
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The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Kava - standardised 240mg kavalactones | Experimental | Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kava (240mg of kavalactones per day) | Dietary Supplement | Kava 60 milligrams per tablet = 240mg of kavalactones per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in score to psychometric questionnaire measures | Depressive symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS), self-rated anxiety on the Beck Anxiety Inventory (BAI), pathological worry on the Penn State Worry Questionnaire (PSWQ), and health-related quality of life on the Short Form Survey-12 (SF-12) will also be significantly improved by Kava over placebo; and | 18 weeks |
To be considered for inclusion in this study, participants will be required to meet the following criteria:
Participants are ineligible to enter the trial if they have any of the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Sarris, PhD | The University of Melbourne and The Melbourne Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane & Women's Hospital | Brisbane | Queensland | 4006 | Australia | ||
| Centre for Human Psychopharmacology - Swinburne University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37960239 | Derived | 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. | |
| 31813230 | Derived | Sarris 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. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Placebo | Dietary Supplement | Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment. |
|
| Monoamine and GABA differential gene expression | Differential gene expression will be assessed from baseline to week 8 from participants in the Melbourne site. This will determine whether Kava increases expression of genes effecting expression of neurochemical e.g. GABA, and monoamines | 8 weeks |
| Melbourne |
| Victoria |
| 3122 |
| Australia |
| 26527536 | Derived | Savage 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. |