Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

NCT02219880 | Completed Phase 4

• 1 other identifier: 137/14
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

Brief Summary

The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.

Conditions

Generalized Anxiety Disorder

Keywords

Kava; Anxiety; Generalized Anxiety Disorder; Psychiatric; Anxiolytic; GABA; Kavalactones

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention

  18 weeks

Other Outcomes (2)

• Changes in score to psychometric questionnaire measures

  18 weeks

• Monoamine and GABA differential gene expression

  8 weeks

Study Arms (2)

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.

Dietary Supplement: Placebo

Kava - standardised 240mg kavalactones

EXPERIMENTAL

Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day

Dietary Supplement: Kava (240mg of kavalactones per day)

Interventions

Kava (240mg of kavalactones per day) DIETARY_SUPPLEMENT

Kava 60 milligrams per tablet = 240mg of kavalactones per day

Also known as: Kava, Kavalactones, Piper methysticum

Kava - standardised 240mg kavalactones

Placebo DIETARY_SUPPLEMENT

Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Melbourne: lead
• Swinburne University of Technology: collaborator
• The University of Queensland: collaborator

Study Sites (2)

Royal Brisbane & Women's Hospital

Brisbane, Queensland, 4006, Australia

Location

Centre for Human Psychopharmacology - Swinburne University

Melbourne, Victoria, 3122, Australia

Location

Related Publications (3)

• 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.

  PMID: 37960239 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.

  PMID: 31813230 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.

  PMID: 26527536 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jerome Sarris, PhD

  The University of Melbourne and The Melbourne Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Jerome Sarris

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 19, 2014
• Study Start: October 13, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

AU (2)