A double-blind comparison of zuclopenthixol tablets with placebo in the treatment of mentally handicapped in-patients with associated behavioural disorders

Abstract

Fifty-two mentally-handicapped in-patients with associated behavioural disorders were entered into this double-blind trial comparing zuclopenthixol dihydrochloride tablets (10 mg) with placebo. The study consisted of a 6-week open phase, in which all patients were treated with zuclopenthixol tablets, followed by a 12-week double-blind phase where approximately half of the patients were transferred to placebo tablets. Demographic data was obtained from the patients at entry to the study. Clinical assessments were performed at weeks 6, 7, 8, 10, 14 and 18 using the Clinical Global Assessment (CGA), a Behavioural Disorder Assessment prepared specially for this study, and a side-effect check list. Analyses of the rating scales showed significant differences in favour of zuclopenthixol at end-point on the item 'improvement in behaviour disorder' from the CGA and at week 14 and end-point on the Assessment of Behavioural Disorder. All other results demonstrated a favourable trend towards the zuclopenthixol treatment. Side-effects were reported slightly more frequently in the zuclopenthixol group, but generally, they were not a problem.