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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Depressive Disorder, Major
• Intervention / Treatment: Drug: Herbal medicine (St. John's wort and Kava)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RBWH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BDI II
BAI
DASS

Secondary Outcome Measures

Outcome Measure
WHOQOL
Daily Mood Monitoring Form

Collaborators and Investigators

• Sponsor: The University of Queensland
• Investigators: Principal Investigator: Jerome Sarris, BHSc, The University of Queensland

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: March 22, 2007
• First Submitted That Met QC Criteria: March 22, 2007
• First Posted (Estimate): March 23, 2007

Study Record Updates

• Last Update Posted (Estimate): May 19, 2008
• Last Update Submitted That Met QC Criteria: May 16, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Anxiety; Psychiatry; Major depressive disorder; Plant, medicine; Major Depressive Disorder with comorbid anxiety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 2006000925