Benefits from mianserin augmentation of fluoxetine in patients with major depression non-responders to fluoxetine alone

Objective: To assess. in depressed patients, the clinical benefit of mianse rin augmentation of fluoxetine or the the benefit of switching treatment fr om fluoxetine to mianserin. Method: In a 6-week double-blind study we compared the therapeutic efficien cy and tolerance of mianserin 60 mg/day (N = 34), mianserin 60 mg/day plus fluoxetine 20 mg/day (N = 32) and continuing fluoxetine 20 mg/day (N = 38) in patients with major depression who did not respond to previous fluoxetin e treatment. Results: Intent-to-treat analysis showed that at week 6 the decrease in the Hamilton Depression rating scale score was significantly (P less than or e qual to 0.03) greater in the mianserin plus fluoxetine group when compared to the fluoxetine group (effect size 0.665). Switching from fluoxetine to m ianserin gave intermediate results. Mianserin augmentation of fluoxetine wa s well tolerated. Conclusion: Mianserin augmentation of fluoxetine in patients nonresponders to fluoxetine 20 mg/day increases response to treatment and is well tolerat ed.