Prevention of poststroke depression: 1 year randomised placebo controlled double blind trial of mianserin with 6 month follow up after therapy

Objectives-(1) To test whether early prophylactic antidepressive treatment by mianserin is able to prevent poststroke depression, and (2) to discover whether mianserin as an antidepressant has any beneficial influence on the outcome of ischaemic stroke. Methods-A randomised, double blind, placebo controlled study involved 100 c onsecutive patients under 71 years old admitted to hospital for an acute is chaemic stroke; they were enrolled to receive 60 mg/day mianserin or placeb o for 1 year. They were examined on admission, and at 2, 6, 12, and 18 mont hs with depression, stroke, and functional outcome scales. Results-According to DSM-III-R, the prevalence of major depression was 6% a t the initial stage, 11% at 1 year, and 16% at 18 months. At no time point did prevalences differ between the treatment groups, nor were differences f ound in depression scales, although at 2 months a greater improvement from initial assessment on the Hamilton depression scale was evident in patients on mianserin (p=0.05). Some beneficial changes on the Hamilton depression scale and Beck depression inventory were found in patients older than 56 (m edian age) and in men treated with mianserin, but not in other subgroups. M ianserin treatment did not affect stroke outcome as measured by neurologica l status, nor did it have any influence on functional outcome as measured b y Rankin scale or Barthel index. Conclusion-It was not possible to show that early initiation of antidepress ant therapy can prevent poststroke depression, because the prevalence of po ststroke depression remained low even in patients on placebo. In this strok e population with a low rate of depressive patients, antidepressive medical treatment failed to affect stroke outcome.