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Remission and recovery associated with lurasidone in the treatment of major depressive disorder with subthreshold hypomanic symptoms (mixed features): post-hoc analysis of a randomized, placebo-controlled study with longer-term extension

  • Joseph F. Goldberg (a1), Daisy Ng-Mak (a2), Cynthia Siu (a3), Chien-Chia Chuang (a2), Krithika Rajagopalan (a2) and Antony Loebel (a4)...
  • Please note a correction has been issued for this article.

Abstract

Objective

This post-hoc analysis assessed rates of symptomatic and functional remission, as well as recovery (combination of symptomatic and functional remission), in patients treated with lurasidone for major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features).

Method

Patients with MDD plus two or three manic symptoms (defined as per the DSM–5 mixed-features specifier) were randomly assigned to flexible-dose lurasidone 20–60 mg/day (n=109) or placebo (n=100) for 6 weeks, followed by a 3-month open-label, flexible-dose extension study for U.S. sites only (n=48). Cross-sectional recovery was defined as the presence of both symptomatic remission (Montgomery–Åsberg Depression Rating Scale score ≤ 12) and functional remission (all Sheehan Disability Scale [SDS] domain scores ≤3) at week 6, and at both months 1 and 3 of the extension study (“sustained recovery”).

Results

A significantly higher proportion of lurasidone-treated patients (31.3%) achieved recovery (assessed cross-sectionally) compared to placebo (12.2%, p=0.002) at week 6. The number of manic symptoms at baseline moderated the effect size for attaining cross-sectional recovery for lurasidone treatment (vs. placebo) (p=0.028). Sustained recovery rates were higher in patients initially treated with lurasidone (20.8%) versus placebo (12.5%).

Conclusions

In this post-hoc analysis of a placebo-controlled study with open-label extension that involved patients with MDD and mixed features, lurasidone was found to significantly improve the rate of recovery at 6 weeks (vs. placebo) that was sustained at month 3 of the extension study. The presence of two (as opposed to three) manic symptoms moderated recovery at the acute study endpoint.

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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: Daisy Ng-Mak, Global Health Economics and Outcomes Research, Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, Massachusetts 01748, USA. (Email: Daisy.Ng-Mak@Sunovion.com)

Footnotes

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This study is registered at Clinicaltrials.gov (no. NCT01421134) and Clinicaltrials.gov (no. NCT01423253).

This research was supported by Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.

Footnotes

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