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Psych Congress  

Optimizing Response to Lurasidone in Patients With Acute Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study of Dosing Regimens

Authors  
Andrei Pikalov, MD, PhD
Antony Loebel, MD
Robert Silva, PhD
Robert Goldman, PhD
Kei Watabe, MS
Josephine Cucchiaro, PhD
John Kane, MD
Sponsor  
Sunovion Pharmaceuticals Inc. ClinicalTrials.gov identifier: NCT01821378.

Objective: To evaluate the efficacy and safety of low-dose lurasidone in patients with schizophrenia and the effect of dose increase in patients demonstrating inadequate initial response to standard-dose lurasidone. Methods: Patients with an acute exacerbation of schizophrenia were randomized to double-blind lurasidone 20 mg/d (n=101), lurasidone 80 mg/d (n=199), or placebo (n=112). After 2 weeks, nonresponders to lurasidone 80 mg/d (Positive and Negative Syndrome Scale [PANSS] score decrease <20%) were re-randomized to lurasidone 80 mg/d or 160 mg/d for the remainder of the study. Results: At Week 6, mean change from baseline in the PANSS total score was not significantly different for lurasidone 20 mg/d compared with placebo (-17.6 vs -14.5; P=0.26). In early responders to lurasidone 80 mg/d (n=100), PANSS total score was significantly reduced at Week 6 compared with placebo (-32.1 vs -14.5; P<0.001; effect size=1.06). In early nonresponders to lurasidone 80 mg/d (n=95), dose increase to lurasidone 160 mg/d at Week 2 significantly reduced PANSS total score at Week 6 study endpoint compared with continuing 80 mg/d (-16.6 vs -8.9; P=0.023; effect size=0.52). The most common adverse events associated with lurasidone therapy (dose groups combined vs placebo) were akathisia (8.7% vs 1.8%), nausea (6.4% vs 3.6%), and vomiting (3.7% vs 0.9%). Conclusions: For patients not responding to 2 weeks of treatment with lurasidone 80 mg/d, dose increase to lurasidone 160 mg/d provided statistically significant and clinically meaningful improvement compared with continuing lurasidone 80 mg/d. Lurasidone 20 mg/d was not efficacious in the treatment of patients with schizophrenia.

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