Objective: To evaluate the efficacy and tolerability of longer-term treatment with lurasidone in patients with major depressive disorder (MDD) with mixed features.
Methods: Patients in the US (N=48) with MDD who presented with 2 or 3 manic symptoms and who completed 6 weeks of double-blind, placebo-controlled treatment with lurasidone 20-60 mg/d were enrolled in a 12-week, open-label (OL) extension study in which patients were continued on lurasidone (Lur-Lur group) or switched from placebo to lurasidone (Pbo-Lur group). The primary efficacy measure was the Montgomery-Åsberg Depression Rating Scale (MADRS).
Results: A total of 48 patients entered the extension study, with a mean MADRS at OL-baseline: Lur-Lur (N=29), 15.0; Pbo-Lur (N=19), 24.1; 9 patients (18.8%) discontinued prematurely. Mean change from OL-baseline to week 12 (OC/LOCF) in MADRS total scores for the Lur-Lur group was -4.1/-3.3, and for the Pbo-Lur group was -11.2/-9.7. In the OL study, adverse events (≥5%) were akathisia (10.4%), diarrhea (8.3%), upper respiratory infection (8.3%), and headache, sedation, nausea, fatigue (6.3% each). For the Lur-Lur and Pbo-Lur groups, respectively, median change in metabolic parameters (DB-baseline to week 12-OC) were as follows: cholesterol (-6.5 and +1.5 mg/dL), triglycerides (-3.5 and +20.0 mg/dL), and HbA1c (+0.15% and +0.30%). There were no clinically significant changes in body weight. Treatment-emergent mania or hypomania as an adverse event occurred in 2 patients (4.2%).
Conclusions: Treatment with lurasidone (20-60 mg/d) was generally safe and well-tolerated for up to 12 weeks in patients with MDD with mixed features. Continued improvement in depressive symptoms was observed.
ClinicalTrials.gov identifier: NCT01423253