[Multicenter double-blind study comparing the efficacy and tolerance of paroxetine and clomipramine in reactive depression in the elderly patient]

Abstract

This multi-centre, double-blind study, carried out in France, was designed to compare the efficacy and tolerability of paroxetine and clomipramine in elderly patients, aged 60 or above, with reactive depression according to Feighner's criteria. Patients were randomly allocated to treatment with either paroxetine (20 mg o.d.), 41 patients, or clomipramine (increasing from 20 mg o.d. to 20 mg tds), 42 patients, for 5 weeks. Placebo tablets were used to maintain blinding. The degree of depression was determined using the Montgomery-Asberg and the Zung self-rating scales, and also assessed on a visual analogue scale. After 5 weeks of treatment both treatment groups showed a similar degree of improvement on all rating scales. There were no significant differences between the groups. Adverse events occurred in 26 and 28 patients in the paroxetine and clomipramine groups, respectively. In the paroxetine group, many of the events were typical of the gastrointestinal side-effects associated with 5-HT uptake inhibitor therapy. Patients receiving clomipramine experienced events of the type commonly reported with tricyclic antidepressants. There were no significant differences between the groups for either total number of events or for number of patients with specific events. Clinical and laboratory monitoring showed that both drugs were well tolerated.