title: Kava Anxiety Depression Spectrum Study (KADSS): a mixed methods RCT using an aqueous extract of Piper methysticum.
abstract: OBJECTIVE
  To report on the design, significance and potential impacts of the first documented human clinical trial assessing the anxiolytic and thymoleptic efficacy of an aqueous mono-extract of Piper methysticum (kava). The significance of the qualitative element of our clinical trial is also explored. The Kava Anxiety Depression Spectrum Study (KADSS) is a 3-week placebo-controlled, double-blind, cross-over trial involving 60 adult participants (18-65) with elevated stable anxiety and varying levels of depressive symptoms.
  
  
  OBJECTIVE
  The aims of KADSS are: (1) to determine whether an aqueous standardised extract of kava is effective for the treatment of anxiety; (2) to assess the effects of kava on differing levels of depression; and (3) to explore participants' experience of taking kava via qualitative research. The study also provides preliminary assessment of the safety of an aqueous extract of kava in humans.
  
  
  CONCLUSIONS
  If results reveal that the aqueous kava preparation exerts significant anxiolytic effects and appears safe, potentially beneficial impacts may occur. Data supporting a safe and effective kava extract may encourage a re-introduction of kava to Europe, UK and Canada. This may provide a major socioeconomic benefit to Pacific Island nations, and to sufferers of anxiety disorders.
authors.affiliation: School of Medicine, University of Queensland, Australia. j.sarris@uq.edu.au
authors.forename: J
authors.initials: J
authors.lastname: Sarris
authors.forename: D J
authors.initials: DJ
authors.lastname: Kavanagh
authors.forename: J
authors.initials: J
authors.lastname: Adams
authors.forename: K
authors.initials: K
authors.lastname: Bone
authors.forename: G
authors.initials: G
authors.lastname: Byrne
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy*; D001008:Anxiety Disorders / Q000188:drug therapy; D003863:Depression / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D020901:Kava; D008875:Middle Aged; D017060:Patient Satisfaction; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D010936:Plant Extracts