A DOUBLE-BLIND COMPARISON OF THE EFFICACY AND SAFETY OF PAROXETINE AND IMIPRAMINE IN THE TREATMENT OF DEPRESSION WITH DEMENTIA

Objectives. To compare the efficacy of paroxetine and imipramine prosp ectively in patients with coexisting depression and dementia. Methods. An 8-week, double-blind, parallel group trial comparing paroxetine 20 -40 mg/day with imipramine 50-100 mg/day in 198 patients aged 60 years or over with a Montgomery-Asberg Depression Rating Scale (MADRS) scor e greater than or equal to 20 and a Folstein mini-mental state evaluat ion score of 17-23 points after a 3- to 7-day placebo run-in period. R esults. Both paroxetine and imipramine reduced the MADRS and the Clini cal Global Impression (CGI) severity-of-illness and global improvement scores at weeks 2, 4, 8 and at endpoint, with no significant differen ces between treatment groups at any timepoint (MADRS, p greater than o r equal to 0.368; cgi, p greater than or equal to 0.286). There was a statistically significant difference in favour of paroxetine at both t he week 4 and week 8 timepoints (analysis of variance, p less than or equal to 0.049) in the Cornell scale for depression in dementia: at en dpoint there was no significant difference between treatments (p = 0.1 03). Treatment-emergent adverse experiences were reported by 51.5% (51 /99) of patients treated with paroxetine and 50.5% (50/99) of patients treated with imipramine. Anticholinergic adverse experiences (paroxet ine 6.1%; imipramine 13.1%) and serious non-fatal adverse experiences (paroxetine 4.0%; imipramine 8.1%) were reported by more patients in t he imipramine group than in the paroxetine group. Conclusions. Paroxet ine and imipramine were both effective in the treatment of depression in elderly subjects with co-existing dementia, and no significant diff erences were detected between the groups. There were trends suggesting that paroxetine was better tolerated than imipramine in terms of anti cholinergic adverse experiences and serious non-fatal adverse experien ces. (C) 1998 John Wiley & Sons, Ltd.