This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.
Objective: To evaluate the effect of lurasidone on depressive and anxiety symptoms in patients with major depressive disorder (MDD) with mixed features with moderate-to-severe levels of anxiety.
Methods: Patients meeting DSM-IV-TR criteria for MDD, with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥26, who presented with 2 or 3 protocol-defined manic symptoms, were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/d (N=108) or placebo (N=100). Severity of anxiety was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). Change from baseline in HAM-A total score (ANCOVA-LOCF) and MADRS total score (MMRM) were analyzed for patients with the following baseline levels of anxiety severity: mild anxiety (HAM-A ≤14) and moderate-to-severe anxiety (HAM-A ≥15).
Results: At baseline, the mean (SD) HAM-A total score for the overall treatment sample was 16.9 (6.4). Moderate-to-severe anxiety was present at baseline in 56.7% of patients. Treatment with lurasidone was associated with significant changes vs. placebo at week 6 in MADRS score in patients with both mild anxiety (-18.4 vs. -12.8; P=0.0086; effect size [ES], 0.59) and moderate-to-severe anxiety (-22.0 vs. -13.0; P<0.001; ES, 0.95); and in the HAM-A total score in patients with both mild anxiety (-7.6 vs. -4.0; P=0.0042; ES, 0.62; LOCF), and moderate-to-severe anxiety (-11.4 vs. -6.1; P<0.0001; ES, 0.91).
Conclusions: In this post-hoc analysis of an MDD with mixed features population, treatment with lurasidone was associated with significant improvements in both depressive and anxiety symptoms in patients with mild and moderate-to-severe baseline levels of anxiety.
Clinicaltrials.gov: NCT01421134 Mood Disorders Psychopharmacology