A comparison of high and low dosage regimes of maprotiline (Ludiomil).

A double-blind, randomized, multicentre trial is described which was designed to compare the clinical effect of 30 mg and 75 mg daily of maprotiline (Ludiomil) administered as either once or thrice daily therapy. Physicians' assessment of patients' progress was made following 7, 14 and 28 days of treatment. Patients also assessed themselves using a visual analogue scale at the same time intervals. Of the 231 patients admitted to the study, 40 dropped out for various reasons, leaving 191 patients completing. Of the 40 drop-outs, drug-induced side-effects were considered to be responsible in the case of 17 patients. No differences between the four treatment groups were demonstrated on the physicians' assessment; however, the patients' self-assessments using the 10 cm visual analogue scale indicated that the 25 mg three times daily regime appeared to be the most satisfactory, but not statistically significantly so, when compared with the 10 mg thrice daily and 75 mg nocte regimes. The 30 mg nocte dose proved to be distinctly inferior.

RCT Entities:   Population Interventions Outcomes