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A double-blind, fixed blood-level study comparing mirtazapine with imipramine in depressed in-patients

1996; Springer Science+Business Media; Volume: 127; Issue: 3 Linguagem: Inglês

10.1007/bf02246131

1432-2072

Jan A. Bruijn, Walter W. van den Broek, Annelienke M. van Hulst, Rose C. van der Mast, B.J.M. van de Wetering, P. Moleman, Paul Mulder,

Electroconvulsive Therapy Studies

Antidepressant effects of mirtazapine and imipramine were compared in a randomized, double blind, fixed blood-level study with in-patients in a single centre. Patients with a DSM-III-R diagnosis of major depression and a Hamilton (17-item) score of ≥18 were selected. After a drug-free and a placebowashout period of 7 days in total, 107 patients still fulfilling the HRSD criterion of ≥18, started on active treatment. The dose was adjusted to a predefined fixed blood level to avoid suboptimal dosing of imipramine. Concomitant psychotropic medication was administered only in a few cases because of intolerable anxiety or intolerable psychotic symptoms. Eight patients dropped out and two were excluded from analyses because of non-compliance; 97 completed the study. According to the main response criterion (50% or more reduction on the HRSD score) 11/51 (21.6%) patients responded on mirtazapine and 23/46 (50%) on imipramine after 4 weeks' treatment on the predefined blood level. Such a dramatic difference in efficacy between antidepressants has not often been reported before. The selection of (severely ill) in-patients, including those with suicidal or psychotic features, may have significance in this respect. Optimization of treatment with the reference drug imipramine through blood level control, exclusion of non-compliance for both drugs, exclusion of most concomitant medication and a low drop-out rate may also have contributed. It is concluded that imipramine is superior to mirtazapine in the patient population studied.