Prevention of poststroke depression: 1 year randomised placebo controlled double blind trial of mianserin with 6 month follow up after therapy
- Heikki Palomäkia,
- Markku Kastea,
- Anu Berga,
- Riitta Lönnqvista,
- Jouko Lönnqvistb,
- Matti Lehtihalmesa,
- Juhani Haresc
- aDepartment of Neurology, University of Helsinki, Finland, bDepartment of Mental Health, National Public Health Institute, Helsinki, Finland, cOrion Corporation, Orion Pharmaceutica, Espoo, Finland
- Dr Heikki Palomäki, Department of Neurology, University of Helsinki, Haartmaninkatu 4, 00290 Helsinki 29, Finland. Telephone 00358 9 471 3949; fax 00358 9 471 4056.
- Received 12 January 1998
- Revised 27 October 1998
- Accepted 6 November 1998
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 consecutive patients under 71 years old admitted to hospital for an acute ischaemic stroke; they were enrolled to receive 60 mg/day mianserin or placebo for 1 year. They were examined on admission, and at 2, 6, 12, and 18 months with depression, stroke, and functional outcome scales.
RESULTS According to DSM-III-R, the prevalence of major depression was 6% at 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 found 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 (median age) and in men treated with mianserin, but not in other subgroups. Mianserin treatment did not affect stroke outcome as measured by neurological status, nor did it have any influence on functional outcome as measured by Rankin scale or Barthel index.
CONCLUSION It was not possible to show that early initiation of antidepressant therapy can prevent poststroke depression, because the prevalence of poststroke depression remained low even in patients on placebo. In this stroke population with a low rate of depressive patients, antidepressive medical treatment failed to affect stroke outcome.