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Completed

NCT Number: NCT00451516

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RBWH

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbal medicine (St. John's wort and Kava)

Drug

Primary outcomes

  1. BDI II

  2. BAI

  3. DASS

Secondary outcomes

  1. WHOQOL

  2. Daily Mood Monitoring Form

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 23, 2007
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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