The efficacy of fluoxetine versus maprotiline in depressed patients and by dose

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Abstract
The aim of this trial was to study the antidepressant effect, to ascertain the optimal dose, and to assess the safety profile of the 5-HT reuptake inhibitor fluoxetine as compared with the noradrenaline reuptake inhibitor maprotiline in a randomized, double-blind, multicentre study in three psychiatric university clinics in Finland. In- and out-patients of either sex, aged 18 to 65 years, and fulfilling Research Diagnostic Criteria for unipolar, major depressive disorders were included. Altogether 46 patients were included, 24 in the fluoxetine group and 22 in the maprotiline group. Twenty-one patients in the former and 18 in the latter group completed the trial. The fluoxetine dose was fixed at 20 mg/day during the first 3 weeks of the study, followed by a 2-week flexible dose period with a dose range from 20 to 60 mg daily. The maprotiline dose was flexible, ranging from 50 to 150 mg/day during the total study period. The patients were assessed before and after the washout period and weekly during the 5-week treatment period. The Hamilton Psychiatric Rating Scale for Depression (HAM-D), the Raskin Depression Scale, the Covi Anxiety Scale, the Clinical Global Impression Scale, and Patient's Global Impression Scale (degrees 1–5) were used to assess efficacy. Results did not indicate marked differences in efficacy between the two treatment groups. On the basis of weekly analysis of scores the mean values were significantly improved with both drugs as assessed from base line to end point. The reduction of symptoms appears to become apparent earlier in the maprotiline group, possibly due to this drug's sedative properties, than in the fluoxetine group. However, in the scores on the suicidal thoughts item of HAM-D there was a significant difference in favour of fluoxetine. The adverse events recorded in both groups, although not significantly different, show a different pharmacologic profile of the drugs. No abnormal laboratory test values were found in the fluoxetine group as compared to three cases with transient abnormally elevated liver enzyme values in the maprotiline group. Most of the patients in the fluoxetine group were treated with a dose of 20 mg/day, which suggests that this should be the dose of choice for the desired antidepressant effect.

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