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
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)

NCT02219880_inc_T1
Person
Aged
NCT02219880_inc_T2
Value
between 18-70 years
NCT02219880_inc_T3
Measurement
Diagnostic and Statistical Manual (DSM) IV and DSM-V diagnostic criteria
NCT02219880_inc_T4
Scope
Meets
NCT02219880_inc_T5
Condition
generalised anxiety disorder
NCT02219880_inc_T6
Condition
GAD
NCT02219880_inc_T7
Procedure
structured interview
NCT02219880_inc_T8
Procedure
Mini International Neuropsychiatric Interview-Plus 6 [MINI-Plus 6]
NCT02219880_inc_T9
Condition
anxiety
NCT02219880_inc_T10
Measurement
Hamilton Anxiety Rating Scale
NCT02219880_inc_T11
Value
= 18
NCT02219880_inc_T12
Temporal
at the time of study entry
NCT02219880_inc_T13
Reference_point
time of study entry
NCT02219880_inc_T16
Condition
GAD
NCT02219880_inc_T17
Condition
Primary diagnosis
NCT02219880_inc_T18
Negation
other than
NCT02219880_inc_T19
Qualifier
moderate to severe
NCT02219880_inc_T20
Condition
depressive symptoms
NCT02219880_inc_T21
Scope
moderate to severe depressive symptoms
NCT02219880_inc_T22
Measurement
Montgomery-Asberg Rating Scale
NCT02219880_inc_T23
Measurement
MADRS
NCT02219880_inc_T24
Value
= 18
NCT02219880_inc_T25
Temporal
at time of study entry
NCT02219880_inc_T26
Value
= 24
NCT02219880_inc_T27
Temporal
at any time during study
NCT02219880_inc_T28
Scope
= 18 at time of study entry or = 24 at any time during study
NCT02219880_inc_T29
Scope
Montgomery-Asberg Rating Scale: MADRS
NCT02219880_inc_T30
Scope
Montgomery-Asberg Rating Scale: MADRS = 18 at time of study entry or = 24 at any time during study
NCT02219880_inc_T31
Condition
suicidal ideation
NCT02219880_inc_T32
Value
= 3
NCT02219880_inc_T33
Measurement
MADRS suicidal thoughts domain
NCT02219880_inc_T34
Temporal
at time of study entry
NCT02219880_inc_T35
Temporal
at any time during study
NCT02219880_inc_T36
Scope
at time of study entry or at any time during study
NCT02219880_inc_T37
Scope
= 3 on MADRS suicidal thoughts domain at time of study entry or at any time during study
NCT02219880_inc_T38
Condition
bipolar disorder
NCT02219880_inc_T39
Condition
schizophrenia
NCT02219880_inc_T40
Measurement
structured interview
NCT02219880_inc_T41
Measurement
MINI Plus
NCT02219880_inc_T42
Scope
bipolar disorder or schizophrenia
NCT02219880_inc_T43
Condition
alcohol use disorder
NCT02219880_inc_T44
Condition
/alcohol der on struc
NCT02219880_inc_T45
Measurement
structured interview
NCT02219880_inc_T46
Measurement
MINI Plus
NCT02219880_inc_T47
Scope
substance/alcohol use disorder
NCT02219880_inc_T48
Drug
antidepressant
NCT02219880_inc_T49
Condition
taking
NCT02219880_inc_T50
Temporal
Currently
NCT02219880_inc_T51
Drug
mood stabiliser
NCT02219880_inc_T52
Drug
antipsychotic
NCT02219880_inc_T53
Drug
anticonvulsant
NCT02219880_inc_T54
Drug
warfarin
NCT02219880_inc_T55
Drug
thyroxin
NCT02219880_inc_T56
Drug
benzodiazepine
NCT02219880_inc_T57
Drug
opioid-based analgesic
NCT02219880_inc_T58
Multiplier
more than 2 days per week
NCT02219880_inc_T59
Multiplier
regular
NCT02219880_inc_T60
Temporal
current
NCT02219880_inc_T61
Scope
benzodiazepine or opioid-based analgesic
NCT02219880_inc_T62
Scope
antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin or thyroxin
NCT02219880_inc_T63
Procedure
use
NCT02219880_inc_T64
Drug
psychotropic nutraceutical
NCT02219880_inc_T65
Condition
St John's wort
NCT02219880_inc_T66
Temporal
Current
NCT02219880_inc_T67
Procedure
use
NCT02219880_inc_T68
Condition
intolerance
NCT02219880_inc_T69
Drug
kava
NCT02219880_inc_T70
Temporal
Previous
NCT02219880_inc_T71
Multiplier
Three or more
NCT02219880_inc_T72
Procedure
trials of pharmacotherapy
NCT02219880_inc_T73
Qualifier
failed
NCT02219880_inc_T74
Condition
GAD episode
NCT02219880_inc_T75
Temporal
current
NCT02219880_inc_T76
Procedure
psychotherapy
NCT02219880_inc_T77
Temporal
within four weeks of study entry
NCT02219880_inc_T78
Temporal
Recently
NCT02219880_inc_T79
Qualifier
clinically unstable
NCT02219880_inc_T80
Qualifier
systemic
NCT02219880_inc_T81
Condition
medical disorder
NCT02219880_inc_T82
Mood
suspected
NCT02219880_inc_T83
Mood
Known
NCT02219880_inc_T84
Scope
Known or suspected
NCT02219880_inc_T85
Condition
hepato-biliary disease
NCT02219880_inc_T86
Condition
isease/inflamm vated liver
NCT02219880_inc_T87
Value
Elevated
NCT02219880_inc_T88
Measurement
liver enzymes
NCT02219880_inc_T89
Temporal
baseline
NCT02219880_inc_T90
Procedure
blood test
NCT02219880_inc_T91
Condition
Pregnancy
NCT02219880_inc_T92
Observation
breastfeeding
NCT02219880_inc_T93
Condition
trying to conceive
NCT02219880_inc_T94
Negation
Not
NCT02219880_inc_T96
Qualifier
medically approved
NCT02219880_inc_T97
Procedure
contraception
NCT02219880_inc_T98
Procedure
abstinence
NCT02219880_inc_T99
Person
female
NCT02219880_inc_T100
Person
childbearing age
NCT02219880_inc_T101
Observation
age
NCT02219880_inc_T102
Value
childbearing
NCT02219880_inc_T103
Scope
childbearing age
NCT02219880_inc_T104
Scope
female and of childbearing age
NCT02219880_inc_T105
Scope
Not using medically approved contraception (including abstinence)
NCT02219880_inc_T95
Observation
Unable to participate
NCT02219880_inc_T106
Visit
scheduled visits
NCT02219880_inc_T107
Observation
treatment plan
NCT02219880_inc_T108
Procedure
trial procedures
NCT02219880_inc_T109
Negation
except for
NCT02219880_inc_T110
Observation
genetic component
NCT02219880_inc_T111
Scope
scheduled visits, treatment plan, or other trial procedures