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St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety

This study has been completed.
Sponsor:
Information provided by:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT00451516
First received: March 22, 2007
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Anxiety Disorders
 Drug: Herbal medicine (St. John's wort and Kava)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Queensland:

Primary Outcome Measures:
  • BDI II
  • BAI
  • DASS

Secondary Outcome Measures:
  • WHOQOL
  • Daily Mood Monitoring Form

Estimated Enrollment: 50
Study Start Date: March 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451516

Locations
Australia, Queensland
RBWH
Brisbane, Queensland, Australia, 4006
Sponsors and Collaborators
The University of Queensland
Investigators
Principal Investigator: Jerome Sarris, BHSc The University of Queensland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451516     History of Changes
Other Study ID Numbers: 2006000925
Study First Received: March 22, 2007
Last Updated: May 16, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of Queensland:
Plant, medicine
Psychiatry
Major depressive disorder
Anxiety
Major Depressive Disorder with comorbid anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
 Mental Disorders
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013