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 mianserin augmentation of fluoxetine or the the benefit of switching treatment from fluoxetine to mianserin. Method: In a 6-week double-blind study we compared the therapeutic efficiency 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 fluoxetine 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 equal to 0.03) greater in the mianserin plus fluoxetine group when compared to the fluoxetine group (effect size 0.665). Switching from fluoxetine to mianserin gave intermediate results. Mianserin augmentation of fluoxetine was well tolerated. Conclusion: Mianserin augmentation of fluoxetine in patients nonresponders to fluoxetine 20 mg/day increases response to treatment and is well tolerated.