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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02219880




Registration number
NCT02219880
Ethics application status
Date submitted
13/08/2014
Date registered
19/08/2014
Date last updated
15/10/2018

Titles & IDs
Public title
Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
Scientific title
Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
Secondary ID [1] 0 0
137/14
Universal Trial Number (UTN)
Trial acronym
KGAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized Anxiety Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Kava (240mg of kavalactones per day)
Other interventions - Placebo

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.

Experimental: Kava - standardised 240mg kavalactones - Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day


Other interventions: Kava (240mg of kavalactones per day)
Kava 60 milligrams per tablet = 240mg of kavalactones per day

Other interventions: Placebo
Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hamilton Anxiety Rating Scale (HAMA) - change in score
Timepoint [1] 0 0
18 weeks
Secondary outcome [1] 0 0
Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention
Timepoint [1] 0 0
18 weeks

Eligibility
Key inclusion criteria
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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Centre for Human Psychopharmacology - Swinburne University - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3122 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Swinburne University of Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Queensland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised,
placebo-controlled study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02219880
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jerome Sarris, PhD
Address 0 0
The University of Melbourne and The Melbourne Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02219880