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Mosolov S.N.
Moskovskiĭ NII psikhiatrii Roszdrava
Malyutin A.V.
Angelini Pharma Rus, Moscow, Russia
Pikalov A.A.
Sunovion Pharmaceuticals Inc, USA
Effect of Lurasidone on symptoms of schizophrenia in five-factor dimensional model: pooled analysis of two short-term, randomized, double-blind, placebo-controlled studies in patients from Russia and Ukraine
Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(12): 29‑37
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To cite this article:
Mosolov SN, Malyutin AV, Pikalov AA. Effect of Lurasidone on symptoms of schizophrenia in five-factor dimensional model: pooled analysis of two short-term, randomized, double-blind, placebo-controlled studies in patients from Russia and Ukraine. S.S. Korsakov Journal of Neurology and Psychiatry.
2019;119(12):29‑37. (In Russ.)
https://doi.org/10.17116/jnevro201911912129
Objective. Evaluation of a new five-factor dimensional model of schizophrenia in recent revisions of classifications of mental disorders (DSM-5 and ICD-11) dictates the need to use this approach in conducting a comprehensive assessment of the effectiveness of new antipsychotic agents, including ethnically homogeneous populations of patients. Material and methods. Post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled, 6-week clinical studies (RCTs) of lurasidone (fixed doses, 40, 80, 120 or 160 mg/d) in patients experiencing an acute exacerbation of schizophrenia. Changes in PANSS total score, CGI-S score and five established PANSS factors were assessed using mixed-model repeated measures analysis. Results. Lurasidone (n=162, dose groups pooled) compared with placebo (n=68), significantly improved the PANSS total score at Week 6 (–23.0 vs. –10.5; p<0.001; effect size 0.82) as well as all PANSS factor scores: positive symptoms (–8.5 vs. –4.2; p<0.001; effect size 0.88), negative symptoms (–4.4 vs. –2.8; p=0.011, effect size 0.44), disorganized thoughts (–4.4 vs. –2.1; p<0.001; effect size 0.70), hostility/excitement (–2.7 vs. –0.7; p<0.001; effect size 0.66), and depression/anxiety (–3.5 vs. –2.2; p=0.002; effect size 0.53). Conclusion. Lurasidone demonstrated significant improvement for both PANSS total score and each of the five PANSS factor scores, indicating effectiveness across the broad spectrum of schizophrenia symptoms. Effect size for both PANSS total score and each of the five PANSS factor scores for the local population was higher than for the wider population, which included patients from various countries.
Authors:
Mosolov S.N.
Moskovskiĭ NII psikhiatrii Roszdrava
Malyutin A.V.
Angelini Pharma Rus, Moscow, Russia
Pikalov A.A.
Sunovion Pharmaceuticals Inc, USA
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