Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219880
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Swinburne University of Technology
The University of Queensland
Information provided by (Responsible Party):
Jerome Sarris, University of Melbourne

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE October 13, 2015
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2014)
Hamilton Anxiety Rating Scale (HAMA) - change in score [ Time Frame: 16 weeks ]
Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention [ Time Frame: 18 weeks ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2014)
Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention [ Time Frame: 16 weeks ]
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
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2015)
  • Changes in score to psychometric questionnaire measures [ Time Frame: 18 weeks ]
    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
  • Monoamine and GABA differential gene expression [ Time Frame: 8 weeks ]
    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
Original Other Pre-specified Outcome Measures
 (submitted: August 17, 2014)
  • Changes in score to psychometric questionnaire measures [ Time Frame: 16 weeks ]
    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
  • Monoamine and GABA differential gene expression [ Time Frame: 8 weeks ]
    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
 
Descriptive Information
Brief Title  ICMJE Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
Official Title  ICMJE Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Dietary Supplement: Kava (240mg of kavalactones per day)
    Kava 60 milligrams per tablet = 240mg of kavalactones per day
    Other Names:
    • Kava
    • Kavalactones
    • Piper methysticum
  • Dietary Supplement: Placebo
    Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Study Arms  ICMJE
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Kava - standardised 240mg kavalactones
    Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day
    Intervention: Dietary Supplement: Kava (240mg of kavalactones per day)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
178
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2014)
210
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219880
Other Study ID Numbers  ICMJE 137/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jerome Sarris, University of Melbourne
Study Sponsor  ICMJE University of Melbourne
Collaborators  ICMJE
  • Swinburne University of Technology
  • The University of Queensland
Investigators  ICMJE
Principal Investigator: Jerome Sarris, PhD The University of Melbourne and The Melbourne Clinic
PRS Account University of Melbourne
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP