Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000536369
Ethics application status
Approved
Date submitted
28/07/2008
Date registered
22/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kava Anxiety Depression Spectrum Study: A Human Clinical Trial to Treat Generalised Anxiety.
Scientific title
Kava Anxiety Depression Spectrum Study: A Human Clinical Trial to Treat Generalised Anxiety.
Secondary ID [1] 262656 0
Nil
Universal Trial Number (UTN)
Trial acronym
KADSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 3468 0
Anxiety 3814 0
Condition category
Condition code
Mental Health 3629 3629 0 0
Anxiety
Mental Health 3996 3996 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an aqueous extract from the peeled root of Kava (Piper methysticum). 5X 2.66g tablets (= 250mg of kavalactones per day) per day of either placebo or kava over 3-weeks.
1 week placebo washout period, followed by 2 x 1 weeks of either kava or placebo. (crossover).
Intervention code [1] 3196 0
Treatment: Drugs
Comparator / control treatment
Placebo tablets (identical coating and size). Excipients- inert fillers e.g. starch
Control group
Placebo

Outcomes
Primary outcome [1] 4524 0
The Hamilton Anxiety Scale
Timepoint [1] 4524 0
Baseline, Weeks 1,2,3
Secondary outcome [1] 7656 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 7656 0
Weeks 0(baseline),1,2,3. True baseline measurement will start from week 1 (after randomisation)
Secondary outcome [2] 8275 0
Beck Anxiety Scale (BAI)
Timepoint [2] 8275 0
Week 1 (randomisation after placebo washout), Week 2, Week 3

Eligibility
Key inclusion criteria
Chronic anxiety >2 weeks (>10 Beck Anxiety Inventory: BAI).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of synthetic antidepressants.
Psychotic/ Bipolar illness.
Significant suicidal ideation in the previous 6 months.
Diagnosed hepato-bilary disease/inflammation.
Substance abuse disorder including alcohol in the previous 6 months.
Use of benzodiazepines or opiates in the previous month.
Previous adverse reaction to kava.
Seeing a psychologist or counsellor currently or in the previous month.
Lack of facility in written or spoken English.
Currently pregnant or lactating

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)
Participants are recuited via the mass media. After a 1 week placebo run-in, non-responders to placebo (excluded if they had >50% reduction on the Hamilton Anxiety Scale (HAMA) or Beck Anxiety Inventory (BAI) are randomly allocated to an active or placebo group, which is crossed-over after one week. Randomisation was instigated by a non-affliated researcher, using randomised permutation. Allocation to Group A or Group B was concelled in an opaque envelope and was opened by a blinded researcher at the time of the participants randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was acheived via comuter-generated permuted block randomisation. Randomisation was stratified for sex, and high and low depression on the Beck Depression Inventory II (BDI II) (above or below 10 on the BDI II i.e. Hi or Low BDI II female; Hi or Low BDI II Male.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3650 0
University
Name [1] 3650 0
University of Queensland
Country [1] 3650 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland, Sir Fred Schonell Drive, St Lucia, Brisbane, Queensland, Australia, 4076.
Country
Australia
Secondary sponsor category [1] 3621 0
None
Name [1] 3621 0
Address [1] 3621 0
Country [1] 3621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5701 0
The University of Queensland Medical Ethics committee
Ethics committee address [1] 5701 0
The University of Queensland, Sir Fred Schonell Drive, St Lucia, Brisbane, Queensland, Australia, 4076.
Ethics committee country [1] 5701 0
Australia
Date submitted for ethics approval [1] 5701 0
Approval date [1] 5701 0
31/03/2008
Ethics approval number [1] 5701 0
2008000340

Summary
Brief summary
KADSS is a 3-week human clinical trial using a water soluble extract of kava to treat anxiety. We aim to determine whether this extract is safe and effective in reducing anxiety. We also are exploring the effects of kava on depression levels.
Trial website
NIL
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 28785 0
Address 28785 0
Country 28785 0
Phone 28785 0
Fax 28785 0
Email 28785 0
Contact person for public queries
Name 11942 0
Jerome Sarris
Address 11942 0
Floor K, Mental Health Centre, Royal Brisbane and Women's Hospital (RBWH). Herston rd, Herston. 4006, Queensland.
Country 11942 0
Australia
Phone 11942 0
07 3878 8989
Fax 11942 0
Email 11942 0
j.sarris.uq.edu.au
Contact person for scientific queries
Name 2870 0
Jerome Sarris
Address 2870 0
Floor K, Mental Health Centre, Royal Brisbane and Women's Hospital (RBWH), Herston rd, Herston, 4006, Queensland
Country 2870 0
Australia
Phone 2870 0
07 3878 8989
Fax 2870 0
Email 2870 0
j.sarris@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.