Morning fluoxetine plus evening mianserin versus morning fluoxetine plus evening placebo in the acute treatment of major depression.

ABSTRACT

In a randomized clinical study the combination of fluoxetine 20 mg daily and mianserin 30 mg daily was compared to fluoxetine 20 mg daily and a mianserin placebo. In total, 34 patients with major depression were randomized, of whom 16 received fluoxetine plus mianserin; 18 patients received fluoxetine plus placebo. Of these patients, 69% completed the planned trial of six weeks in the fluoxetine plus mianserin group while 61% completed in the fluoxetine plus placebo group. In the efficacy analysis (excluding dropouts from the first two weeks of treatment) the combination of fluoxetine and mianserin was superior to fluoxetine and placebo both in observer ratings of depression and in quality of life ratings. However, in the intention-to-treat analysis this difference was not statistically significant. No major side effects were reported. After four weeks of treatment headache was most often seen in the fluoxetine and mianserin combination, while sweating was most often seen in the fluoxetine plus placebo group. No pharmacokinetic interaction in terms of fluoxetine plasma levels was found in the mianserin-treated patients.