The Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial.

Abstract

The aim of this double-blinded randomised placebo-controlled trial was to investigate the efficacy of clonidine for delirium in medical inpatients greater than 65years. Acutely admitted medical patients greater than 65years with delirium or subsyndromal delirium were eligible for inclusion. Included patients were given a loading dose of either placebo or clonidine; 75μg every third hour up to a maximum of four doses to reach steady state and further 75μg twice daily until delirium free for 2days, discharge or a maximum of 7days of treatment. The primary endpoint was the trajectory of the Memorial Delirium Assessment Scale (MDAS) for the 7days of treatment. Presence of delirium according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and severity measured by MDAS were assessed daily until discharge or a maximum of 7days after end of treatment. Because of slower enrolment than anticipated, the study was halted early. Ten patients in each group were studied. The low recruitment rate was mainly due to the presence of multiple patient exclusion criteria for patient safety. There was no significant difference between the treatment group in the primary endpoint comparing the trajectory of MDAS for the 7days of treatment using mixed linear models with log transformation, (P=.60). The treatment group did not have increased adverse effects. No effect of clonidine for delirium was found, although the study was under powered. Further studies in less frail populations are now required.