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Workshop on the clinical pharmacology and efficacy of mianserin.

A. COPPEN (UK): Perhaps I could begin by presenting data from my own trial (Coppen et al., 1976), in which we compared mianserin with amitriptyline in a group of depressive in-patients. They were treated for 6 weeks after an initial drug-free evaluation period of 7-10 days. The patients were rated every 2 weeks on the Hamilton Rating Scale for depression, and there was no significant difference between the patients' response to amitriptyline or to mianserin. Professor Turner said earlier in the meeting that you should be able to show that the trial design you are using can differentiate between treatments. We have looked at a drug called FG4963, a re-uptake inhibitor, and compared it with amitriptyline using exactly the same design as we did with mianserin (Ghose et al., 1977). We have shown that amitriptyline is significantly superior to FG4963. I therefore think that differences can be shown using this design. We divided our patients according to the Newcastle scale, into endogenous and reactive, and found little difference in response between the reactive and the endogenous patients. We always measure side-effects using the corrected side-effects technique which was pioneered in Professor Cronholm's department. One does this by measuring the side-effects before the patient starts treatment, when he is usually on a placebo. This, of course, measures the subjective feelings of depression. The side-effect chart is then administered subsequently when the patient is on the drug, and the baseline score is then subtracted from the score during treatment, to get the corrected side-effects score which is presumably due to the action of the drug. The patients on amitriptyline showed an increase in side-effects, but those receiving mianserin showed a decrease in reported side-effects which we attributed to their clinical improvement. At 6 weeks, there was a very significant difference between the amitriptyline-treated patients and the mianserin-treated patients. I think that unless you use this sort of technique, it is almost impossible to make any sense at all of side-effects. In summary, we found in a double-blind study that mianserin had roughly the same antidepressant effect as amitriptyline but significantly less side-effects.