Dosing of neuroleptics in elderly demented patients with aggressive and agitated behaviour: a double-blind study with...

A double-blind controlled trial was carried out in 73 hospitalized elderly patients to evaluate the effect of different low doses of the neuroleptic, zuclopenthixol, on behavioural disorders associated with dementia. Patients were randomized into four groups and received treatment for 4 weeks with fixed daily doses of 2 mg, 4 mg or 6 mg zuclopenthixol, or with a dose which could be increased from 4 mg to 20 mg daily. The dose could also be reduced if necessary. Fifty-four of the patients remained on the same daily dose throughout the study. The results of symptom assessments showed that there was a significant improvement from baseline scores in all of the dose groups and, with the exception of patients on 2 mg daily, this was evident after only 1 week of treatment. Although improvement was noted in all the symptoms evaluated, the best effect was achieved on aggressive behaviour, restlessness/agitation, sleep disorders, and shouts/torments others. Only a few, relatively mild side-effects were recorded and there was no increase in frequency with increasing doses. There was significant correlation between the serum concentration and the dose of zuclopenthixol used but not in connection to age and clinical efficacy.