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 prospectively 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) score > or = 20 and a Folstein mini-mental state evaluation score of 17-23 points after a 3- to 7-day placebo run-in period. RESULTS: Both paroxetine and imipramine reduced the MADRS and the Clinical Global Impression (CGI) severity-of-illness and global improvement scores at weeks 2, 4, 8 and at endpoint, with no significant differences between treatment groups at any timepoint (MADRS, p > or = 0.368; cgi, p > or = 0.286). There was a statistically significant difference in favour of paroxetine at both the week 4 and week 8 timepoints (analysis of variance, p < or = 0.049) in the Cornell scale for depression in dementia: at endpoint there was no significant difference between treatments (p = 0.103). 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 (paroxetine 6.1%; imipramine 13.1%) and serious non-fatal adverse experiences (paroxetine 4.0%; imipramine 8.1%) were reported by more patients in the imipramine group than in the paroxetine group. CONCLUSIONS: Paroxetine and imipramine were both effective in the treatment of depression in elderly subjects with co-existing dementia, and no significant differences were detected between the groups. There were trends suggesting that paroxetine was better tolerated than imipramine in terms of anticholinergic adverse experiences and serious non-fatal adverse experiences.