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Psych Congress  

Efficacy and Safety of Treatment with Lurasidone Adjunctive With Lithium or Valproate in Bipolar I Depression: Results of Two 6-Week Studies

Authors  
Joseph Calabrese, MD
Trisha Suppes, MD, PhD
Kaushik Sarma, MD
Robert Silva, PhD
Hans Kroger, MPH, MS
Josephine Cucchiaro, PhD
Andrei Pikalov, MD, PhD
Antony Loebel, MD
Sponsor  
Sunovion Pharmaceuticals Inc.

Objectives: To evaluate the efficacy and safety of lurasidone adjunctive with lithium (Li) or valproate (VPA) in bipolar I depression.

Methods: Data were pooled from 2 studies in which patients with bipolar I depression received 6 weeks of double-blind treatment with lurasidone 20-120 mg/d (N=355) or placebo (N=327), adjunctive with Li or VPA. The primary and key secondary efficacy measure were, respectively, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression, Bipolar - Severity of Illness Scale (CGI-BP-S), analyzed by a mixed-effects model for repeated measures (MMRM). Results: At Week 6, treatment with lurasidone (vs placebo) was associated with improvement in the mean MADRS (-14.4 vs -11.9; P=0.003), CGI-BP-S (-1.7 vs -1.3; P=0.001), and most secondary efficacy measures. Responder rates (MADRS reduction ≥50%) were significantly higher with lurasidone vs placebo (48% vs 37%; P=0.002). Minimal changes were observed for lurasidone (vs placebo) in mean weight (+0.1 vs +0.2 kg), median total cholesterol (-4.0 vs -1.0 mg/dL), triglycerides (+4.0 vs -2.0 mg/dL), and glucose (0.0 vs 0.0 mg/dL). Discontinuation rates due to adverse events were similar for lurasidone vs placebo (5.8% vs 4.8%); adverse events (≥5% incidence) were nausea (13.9% vs 10.2%), Parkinsonism (12.8% vs 8.1%), somnolence (11.4% vs 5.1%), and akathisia (10.8% vs 4.8%).

Conclusions: Results of this pooled analysis demonstrated that lurasidone, adjunctive with and Li or VPA, was an effective treatment of bipolar depression, with a low rate of discontinuation due to adverse events, and minimal effect on weight or metabolic parameters.

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