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

Primary Purpose

Depressive Disorder, Major, Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Herbal medicine (St. John's wort and Kava)
Sponsored by
The University of Queensland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Plant, medicine, Psychiatry, Major depressive disorder, Anxiety, Major Depressive Disorder with comorbid anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RBWH

Outcomes

Primary Outcome Measures

BDI II
BAI
DASS

Secondary Outcome Measures

WHOQOL
Daily Mood Monitoring Form

Full Information

First Posted
March 22, 2007
Last Updated
May 16, 2008
Sponsor
The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT00451516
Brief Title
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
Official Title
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Queensland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Anxiety Disorders
Keywords
Plant, medicine, Psychiatry, Major depressive disorder, Anxiety, Major Depressive Disorder with comorbid anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Herbal medicine (St. John's wort and Kava)
Primary Outcome Measure Information:
Title
BDI II
Title
BAI
Title
DASS
Secondary Outcome Measure Information:
Title
WHOQOL
Title
Daily Mood Monitoring Form

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome Sarris, BHSc
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
RBWH
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia

12. IPD Sharing Statement

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

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