Measuring the efficacy of psychopharmacological treatment of psychomotoric restlessness in dementia: clinical evaluation of tiapride.

A major problem in psychogeriatrics is the treatment of demented patients suffering from severe restlessness and aggressive behavior. There have been few controlled studies of the efficacy of antipsychotic drugs in the treatment of this condition. Therefore, a multi-centre, double-blind, randomized study, measuring the efficacy and safety of tiapride vs. melperone in hospitalized dementia patients suffering from psychomotoric agitation, was conducted in 24 psychiatric hospitals in Germany. A total of 176 patients were enrolled: 175 of them were included in the safety analysis and 156 were evaluated for efficacy. Both treatment groups were comparable regarding the severity of disease and demographic data as well as with regard to the neuropsychological baseline assessment. The CGI (item, 2) was the primary efficacy parameter. Both groups yielded an identical response rate of 74.36%. The secondary efficacy parameters (NOSIE, AIMS, RAPSU, BePU, VAS) showed correspondingly a marked improvement for both groups. No significant changes of the safety parameters (blood pressure, pulse rate, ECG, clinical examination) occurred in the study. The overall number of adverse events was slightly higher in the tiapride group, serious events occurring less frequently. This study demonstrates that tiapride is as effective and as safe as melperone. These results are consistent with international experience on tiapride.

RCT Entities:   Population Interventions Outcomes