None listed
Conditions
Brief summary
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.
Interventions
Each participant will be required to consume 1 dose of Kava tablets (120mg of kavalactones) or 1 dose of Placebo tablets. The placebo tablets are made from microcellulose and are identical in taste and appearance to their active counterpart.
Interventions used for the first 3 weeks of the controlled phase of the trial: Group 1) 1 Kava tablet prescribed twice per day (standardised for 120 mg of kavalactones per day: active constituent); Group 2) 1 placebo tablet twice per day.
Before randomis
Each participant will be required to consume 1 dose of Kava tablets (120mg of kavalactones) or 1 dose of Placebo tablets. The placebo tablets are made from microcellulose and are identical in taste and appearance to their active counterpart. Interventions used for the first 3 weeks of the controlled phase of the trial: Group 1) 1 Kava tablet prescribed twice per day (standardised for 120 mg of kavalactones per day: active constituent); Group 2) 1 placebo tablet twice per day. Before randomisation occurs, a one week placebo run-in will be employed, with any responders having a >50% reduction on the Hamilton Anxiety Scale (HAM-A) to be excluded. After 3 weeks of the controlled phase, non-responders will be given an extra tablet (a doubling of the dose- either double placebo or 240mg of Kava: still within TGA recommended dosage range). All participants will be switched to placebo during Week 8 to observe any occurrence of rebound anxiety or withdrawal symptoms.
Sponsors
Integria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Any person aged 18-65 presenting with a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Structured Clinical Interview for DSM (SCID) diagnosed GAD, and a HAM-A of >14.
Exclusion criteria
Primary diagnosis other than GAD; Psychotic or Bipolar illness; Significant suicidal ideation in the previous 6 months; antidepressant, mood stabiliser, antipsychotic, opiod analgesics, St John’s wort, Human immunodeficiency virus (HIV), anti-tumoral/cancer, blood pressure, warfarin, Parkinson’s, epileptic, migraine or anti-ulcer medication; Diagnosed hepato-biliary disease/inflammation (or elevated liver enzymes at Baseline blood test); Thyroid disease (or thyroid hormone abnormality at baseline blood test); DSM-IV diagnosed substance abuse or dependency disorder including alcohol in the previous 6 months; Regular use of Kava in the previous 12 months; Previous adverse reaction to Kava; Seeing a psychologist or counsellor currently or in the previous month; Pregnancy or trying to conceive; Lack of facility in written or spoken English; Montgomery-Asberg Depression Rating Scale (MADRS) score of >18.
Outcome results
None listed