The aim of the prospective open post-marketing study was to evaluate safety and efficacy of tiapride (Tiapridal® drops) in a large sample of geriatric patients with behavioural disturbances particularly with psychomotor restlessness, agitation and aggression. 1029 community care and long-term nursing care in-patients aged 65 + with an acute (less than 48 hours) onset of behavioural symptoms were enrolled in the study. The average age of the sample was 81±7.5 years. Tiapride at a daily dosage of 300 mg reduced the intensity of behavioural symptoms already after 2 days of treatment. Percentage of symptom intensity reduction assessed by BARS scale (Brief Agitation Rating Scale) reached – 35% and – 47% respectively after one and 2 weeks of treatment (p<0.001). A clinically significant therapeutic effect (Clinical Global Impression - CGI) was seen after 2, 7 a 14 days of treatment in 55.5% to 88.6% of treated patients. Only 0.8% of treated patients dropped out from the study for insufficient efficacy. Adverse events were reported by 8.75% of treated patients, the most prevalent being somnolence, apathy, infections, cardiovascular symptoms. Only 1.2% withdrew due to adverse events. Tiapride (Tiapridal® drops) proved to be an efficient and safe psychotropic drug for symptomatic treatment of acute behavioural disturbances in the elderly population.

        Key words: behavioural disturbances, elderly, pharmacotherapy, tiapride.