The Kava & Anxiety Lowering Medication (KALM) study

The design of the study is a phase IV, 2-arm, 8-week, randomised, double-blind, placebo-controlled trial using one 3.2 gram tablet of Kava (Piper methysticum), twice per day equal to 120mg of kavalactones (but in non-responders at week 3 this will be doubled to two tablets twice per day equal to 240mg of kavalactones), or matching placebo, in 100 currently anxious participants with diagnosed generalised anxiety disorder (GAD). Participants are required to fill out assessment forms throughout the study and to have 3 blood tests (liver function tests and a genetic test providing information on liver enzyme function and neurochemistry). Assessment will occur at Healthscope hospital sites in Victoria and at Swinburne University of Technology, Hawthorn VIC. Data collection will occur during week 0 at baseline and at weeks 1,2,4,7,8 by trained research assistants. Assessment tools used: Compulsory a) Structured Clinical Interview for DSM disorders (automated version) b) HAM-A (primary outcome) c) MADRS d) Weekly safety checklists (for adverse reactions) e) Current health & medications questionnaire to assess their current health and any medications they are currently taking f) Drug Check to assess alcohol and other drug use g) Demographics questionnaire to assess age, education, marital status, employment h) The Arizona Sexual Experience Scale (ASEX) to assess the difference in sexual dysfunction between paroxetine, placebo, and Kava. i) Addiction assessment scale to observe whether any perceived addictiveness to the interventions is occurring j) Three blood tests (liver function test and a genetic test providing information on liver enzyme function and neurochemistry). Participants will be required to attend 6 visits at the Brain Science Institute, Hawthorn. The first visit is a baseline session. Participants will be asked to complete all tests: screening assessments, consent forms, mood and anxiety questionnaires. Testing for all subsequent visits will follow the same outline of their baseline session (excluding consent forms and including an adverse effects safety questionnaire). Participants will be given $100 each at the completion of the study to compensate for their time and to cover travel expenses if required. The recruitment, data collection and analysis period will be approximately 1 year. Data will be analysed by research team using SPSS 17.0. Repeated measures ANOVAs will be used to assess any changes between groups across time.