Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
NCT ID: NCT02219880
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
178 participants
INTERVENTIONAL
2015-10-13
2018-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
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.
Placebo
Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Kava - standardised 240mg kavalactones
Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day
Kava (240mg of kavalactones per day)
Kava 60 milligrams per tablet = 240mg of kavalactones per day
Interventions
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Kava (240mg of kavalactones per day)
Kava 60 milligrams per tablet = 240mg of kavalactones per day
Placebo
Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Swinburne University of Technology
OTHER
The University of Queensland
OTHER
University of Melbourne
OTHER
Responsible Party
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Jerome Sarris
Dr Jerome Sarris
Principal Investigators
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Jerome Sarris, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Melbourne and The Melbourne Clinic
Locations
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Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia
Centre for Human Psychopharmacology - Swinburne University
Melbourne, Victoria, Australia
Countries
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References
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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.
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.
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.
Other Identifiers
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137/14
Identifier Type: -
Identifier Source: org_study_id
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