An 8-week randomised, reference-controlled, double-blind, multicentre clinical trial investigated kava kava LI 150 in generalised anxiety disorder (GAD; ICD-10). A total of 129 outpatients received 400 mg Kava LI 150, 10 mg buspirone or 100 mg Opipramol daily for 8 weeks. At week 9, subjects were seen to check for symptoms of withdrawal or relapse. Primary outcome measures were the HAMA scale and the proportion of responders at week 8. No significant differences could be observed for efficacy and safety measures. About 75% of patients were classified as responders (50% reduction of HAMA score) in each treatment group and about 60% achieved full remission.