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

Sponsor

The University of Queensland (Other)

Overall Status

Completed

CT.gov ID

NCT00451516

Collaborator

(none)

Enrollment

Location

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

BDI II []
BAI []
DASS []

Secondary Outcome Measures

WHOQOL []
Daily Mood Monitoring Form []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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