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Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis

  • Alan C. Swann (a1), Maurizio Fava (a2), Joyce Tsai (a3), Yongcai Mao (a3), Andrei Pikalov (a3) and Antony Loebel (a3)...

Abstract

Objective

The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability.

Methods

The data in this analysis were derived from a study of patients meeting DSM–IV–TR criteria for unipolar MDD, with a Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/d (n=109) or placebo (n=100). We defined “irritability” as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability.

Results

Some 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (–22.6 vs. –9.5, p<0.0001, effect size [ES]=1.4) and without (–19.9 vs. –13.8, p<0.0001, ES=0.7) irritability. In patients with irritable features, treatment with lurasidone was associated with significant week 6 changes vs. placebo in both the YMRS irritability item (–1.4 vs. –0.3, p=0.0012, ES=1.0) and the YMRS disruptive-aggressive item (–1.0 vs. –0.3, p=0.0002, ES=1.2).

Conclusions

In our post-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited

Corresponding author

*Address correspondence to: Antony Loebel, MD, Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, New Jersey 07024. (Email: antony.loebel@sunovion.com)

Footnotes

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This work was supported by Sunovion Pharmaceuticals. Dr. Edward Schweizer, of the Paladin Consulting Group, provided editorial and medical writing assistance, which was funded by Sunovion Pharmaceuticals.

Footnotes

References

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