Objective: To evaluate the efficacy of lurasidone in treating pediatric patients with bipolar depression who presented with high levels of anxiety.
Methods: Patients 10-17 years of age with bipolar I depression were randomized to 6 weeks of double-blind treatment with lurasidone 20-80 mg/d (N=173) or placebo (N=170). The primary efficacy measure was the Children’s Depression Rating Scale, Revised (CDRS-R) total score. In this post-hoc analysis we analyzed efficacy in the subgroup of patients who presented with moderate-to-severe anxiety (high levels; baseline Pediatric Anxiety Rating Scale [PARS] score ≥15) and mild-to-low anxiety (low levels; baseline PARS score <15).
Results: At baseline, 112/343 patients (32.7%) met criteria for high levels of anxiety (mean CDRS-R, 62.1; mean PARS, 19.7) and 67.3% met criteria for low levels of anxiety (CDRS-R, 57.4; PARS, 7.0). Treatment with lurasidone was associated with significantly greater improvement at week 6 vs. placebo on the CDRS-R total score in patients with high anxiety (-22.9 vs. -15.8; P=0.004; effect size, 0.58) and in patients with low anxiety (-20.4 vs. -15.3; P=0.004; effect size, 0.40). In the high anxiety group, treatment with lurasidone was associated with numerically greater reduction at week 6 vs. placebo in the PARS score (-6.2 vs. -5.3; n.s.).
Conclusions: In this post-hoc analysis, treatment with lurasidone significantly improved depressive symptoms in child and adolescent patients with bipolar depression who presented with moderate-to-severe levels of concurrent anxiety. Notably, effect sizes for reduction of depressive symptoms were larger in patients with prominent anxiety.
Clinicaltrials.gov identifier: NCT02046369