Safety measureswere employed to report any adverse events, physical examinations and laboratoryassessments were conducted, and a global judgement of tolerability were evaluatedby patients and investigators. The primary outcome to treatment was determinedby the relative difference of the HAM-D(17) from baseline and secondary outcomewere the depression sub-scores of the various scales and instruments usedthroughout the study.
The sample size (n=201) was an estimator of 0.65 with 65%of LI160 (n=101) and 35% for placebo (n=100). Baseline data were examinedbetween groups using a confidence interval (CI) through the means of the Mann-Whitney-U-Test.The percentage decline of the HAM-D was not statistically significant (p=0.051).
Moreover, there were nosignificant benefit that could be detected for the sum score of the atypicalvegetative items of the HAM-D(28). Although,other various scales and measures such as PHQ-9, HAM-A, and CGI scales all shownto demonstrate superiority to the LI160 extract (p<0.01). In regards to the study there were no deaths and onlyone serious adverse event which required discontinuation of the study drug andno drug interactions were reported.
Overall, the authors concluded that eventhough the primary outcome response of the trial was negative and missed statisticalsignificance in HAM-D(17) (p=0.051)with further evaluation of the secondary outcome that included various scalesand measures such as CGI, PHQ-9, and HAM-A was taken into account and strongly supportedfor the efficacy of LI160 in atypical depressive patients.