Evaluation of efficacy of neuroleptics in open versus double-blind trials:objective

Objective: Due to methodological reservations, results concerning the effic acy of neuroleptics in open trials are often regarded with doubt. Until now , there are nearly no studies comparing findings of controlled double-blind with those of open trials. Aim of this study was to investigate if results of an open or double-blind approach differ and hereby to gain information about the validity of open trials. Methods: After a literature research, fi ve neuroleptics were identified for which at least 3 open and 3 double-blin d trials exist which met the inclusion criteria and from which either the r eduction of the BPRS (Brief Psychiatric Rating Scale)-score or the response rate could be determined. Results: There were no differences in the reduct ion of the BPRS-score or response rate for all 5 neuroleptics between open and double-blind trials. Furthermore, the efficacy of all 5 neuroleptics wa s comparable. Con-elusions: Double-blind controlled studies are essential i n the investigation of new compounds. But results of methodologically well performed open studies are valid and deserve more attention. Preceding open trials may help in the design of double-blind studies.