Clinical effects of mianserin in endogenous depression and their relationship to drug plasma level.

This was a single-blind, open study undertaken to assess the antidepressant efficacy of mianserin, a new tetracyclic antidepressant in in-patients with major depression (DSM III). The relationship between steady state plasma levels and clinical response, and the predictability of steady-state mianserin plasma levels from a single point determination after an initial dose of the drug were also studied. There was remarkable clinical improvement as measured by the significant (P 0.001) reduction in mean HDRS scores after first week of active treatment which continued till day 28 when mean HDRS scores were reduced to about 50% of initial mean scores. There was a modest correlation (r = 0.623, n.s.) between the steady state levels of mianserin and the plasma concentration 12 hours after initial dose. No significant cardiovascular effect was noted throughout the course of treatment. Mianserin is a safe, efficacious antidepressant with minimal cardiovascular effects. Further clinical investigations of this new useful drug are recommended.