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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/NCT00451516




Registration number
NCT00451516
Ethics application status
Date submitted
22/03/2007
Date registered
23/03/2007
Date last updated
19/05/2008

Titles & IDs
Public title
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
Scientific title
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
Secondary ID [1] 0 0
2006000925
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Anxiety Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Herbal medicine (St. John's wort and Kava)

Treatment: Drugs: Herbal medicine (St. John's wort and Kava)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BDI II
Timepoint [1] 0 0
Primary outcome [2] 0 0
BAI
Timepoint [2] 0 0
Primary outcome [3] 0 0
DASS
Timepoint [3] 0 0
Secondary outcome [1] 0 0
WHOQOL
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Daily Mood Monitoring Form
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Any person male or female aged 18-65 presenting with a diagnosis of unipolar
depression confirmed by CIDI auto (quantified by BDI) and an anxiety score on the DASS
of 8 or above i.e. the mean (quantified also by BAI)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Psychotic/ Bipolar illness

- Current or < 6 month significant suicidal ideation

- Diagnosed hepato-biliary disease/inflammation

- Current or < 6 month substance abuse disorder including alcohol

- Current or < 12 month use of kava, St. John's wort,

- Current or < 1 month of synthetic antidepressants or benzodiazepines

- Previous reaction to kava or St. John's wort

- Medications that maybe pharmacokinetically altered via St. John's wort including:

- Amitriptyline anti-coagulants e.g. phenprocoumon, warfarin,

- Anti-fugals e.g. voriconazole,

- Anti-histamines e.g. fexofenadine,

- Benzodiazepines e.g. alprazolam,

- Chemotherapeutics e.g. irinotecan, digoxin, HIV medication (anti-retrovirals), *
Immunosuppressants e.g. cyclosporine, methadone, OCP,

- Statins e.g. simvastatin, warfarin (Henderson 2002; Izzo 2004).

- However this interactions are based on case studies and theoretical interactions
and are regarded to be induced by hyperforin (a constituent of St. John's wort);
low or non-standardised hyperforin preparations are regarded to not induce drug
interactions as little induction of P-glycoprotein and CYP P450 enzymes occurs
(Madabushi et al. 2006). Although in vitro studies have confirmed that kava and
the isolated kavalactones modulate certain CYP 450 enzymes, no documented
evidence of human kava-drug pharmacokinetic interactions exists (Mathews,
Etheridge & Black 2002; Singh 2005)

- Seeing a psychologist or counsellor currently or in the previous month.

- Non-English speakers.

- Pregnancy

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?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
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
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RBWH - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating
anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety
commonly occurs, it is conceivable that a combination of an established antidepressant agent
such as SJW and an established anxiolytic agent such as kava may effectively treat MDD
presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may
also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid
anxiety, than by the individual substances alone. Determination of this is not addressed in
this study due to limitations of time and resources. The determination of the strength of the
SJW-kava combination will be ascertained by comparing similar trials using SJW and kava
mono-therapy in addressing MDD and GAD.

The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid
anxiety more than placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00451516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jerome Sarris, BHSc
Address 0 0
The University of Queensland
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/NCT00451516