Lurasidone in the Treatment of Acute Schizophrenia

Nakamura, Mitsutaka; Ogasa, Masaaki; Guarino, John; Phillips, Debra; Severs, Joseph; Cucchiaro, Josephine; Loebel, Antony

doi:10.4088/jcp.08m04905

Cited by 183 publications

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“…Two previously reported phase II studies demonstrated significantly greater efficacy for lurasidone compared with placebo [Nakamura et al 2009;Ogasa et al 2013].…”

mentioning

confidence: 93%

A 6-week, double-blind, placebo- and haloperidol-controlled, phase II study of lurasidone in patients with acute schizophrenia

Potkin

Kimura

Guarino

2015

Therapeutic Advances in Psychopharmacology

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Objective: The objective of this study was to evaluate the short-term efficacy and safety of the atypical antipsychotic agent lurasidone in the treatment of schizophrenia. Methods: In this phase II, randomized, double-blind, placebo-controlled study, hospitalized adult patients diagnosed with schizophrenia and experiencing an acute exacerbation of psychotic symptoms were randomly assigned to 6 weeks of fixed-dose lurasidone 20 mg/day ( n = 71), lurasidone 40 mg/day ( n = 67), lurasidone 80 mg/day ( n = 71), haloperidol 10 mg/day ( n = 72, included to test for assay sensitivity), or placebo ( n = 72). Efficacy was assessed using the brief psychiatric rating scale, positive and negative syndrome scale, and clinical global impression-severity. Safety assessments included incidence of adverse events and clinical laboratory measures. Results: Numerical improvement was observed from baseline to week 6 (last observation carried forward) on all efficacy measures in all treatment groups; however, no statistically significant differences were noted between any lurasidone group and placebo, or between haloperidol and placebo. The most common adverse events in lurasidone-treated patients, with an incidence of at least 10% (dose groups combined) and greater than placebo, were sedation (15.3%), dyspepsia (13.4%), nausea (13.4%), akathisia (12.4%), and vomiting (10.5%); for haloperidol, the most common adverse events (incidence ⩾ 10% and greater than placebo) were extrapyramidal disorder (20.8%), sedation (19.4%), akathisia (19.4%), dystonia (15.3%), insomnia (13.9%), and somnolence (12.5%). Lurasidone was associated with minimal changes in weight, metabolic parameters, and prolactin levels. Conclusions: None of the lurasidone groups separated from placebo in this clinical study of patients with acute schizophrenia. In addition, haloperidol, which was included for assay sensitivity, did not separate from placebo, resulting in a failed study. Possible reasons for the lack of assay sensitivity in this study include the use of multiple active treatment arms and the relatively large placebo response. Consistent with other studies, lurasidone was generally safe and well tolerated, with minimal effects on weight or metabolic parameters.

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“…Two previously reported phase II studies demonstrated significantly greater efficacy for lurasidone compared with placebo [Nakamura et al 2009;Ogasa et al 2013].…”

mentioning

confidence: 93%

A 6-week, double-blind, placebo- and haloperidol-controlled, phase II study of lurasidone in patients with acute schizophrenia

Potkin

Kimura

Guarino

2015

Therapeutic Advances in Psychopharmacology

Self Cite

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“…[1][2][3][4][5] However, efficacy was not consistently shown for each dose and a dose-response relationship was not evident in the trials. For example, in a study of lurasidone 40 mg, 80 mg and 120 mg, only the 80 mg dose had a statistically significant effect over placebo.…”

Section: New Drugsmentioning

confidence: 93%

“…4 Discontinuation rates were very high in some of the trials (28-65%). [1][2][3][4][5] Lack of efficacy and withdrawal of consent were the most common reasons for stopping treatment.…”

Section: New Drugsmentioning

confidence: 99%

“…[1][2][3][4][5] After six weeks of treatment, once-daily doses of 40 mg, 80 mg, 120 mg and 160 mg significantly lowered signs and symptoms of The most common adverse events in the short-term trials were somnolence (17% of patients), extrapyramidal symptoms (14%), akathisia (13%), insomnia (10%) and nausea (10%). Tachycardia, blurred vision, abdominal pain, diarrhoea, decreased appetite, rash, pruritus, hypertension and elevated creatine kinase also occurred in 1-10% of people.…”

Section: New Drugsmentioning

confidence: 99%

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New drugs: Lurasidone for schizophrenia

2016

Aust Prescr

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“…Lurasidone has demonstrated efficacy in acute and long-term treatment of schizophrenia, [24][25][26] as well as in treatment of bipolar depression, both as monotherapy and as an adjunctive therapy with lithium or valproate. 27,28 The purpose of the present post-hoc analysis was to assess the efficacy of lurasidone in treating MDD patients with mixed features presenting with irritability.…”

Section: Introductionmentioning

confidence: 99%

Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis

et al. 2017

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Objective. The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability.Methods. The data in this analysis were derived from a study of patients meeting DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/d (n = 109) or placebo (n = 100). We defined "irritability" as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability.Results. Some 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (-22.6 vs. -9.5, p < 0.0001, effect size [ES] = 1.4) and without (-19.9 vs. -13.8, p < 0.0001, ES = 0.7) irritability. In patients with irritable features, treatment with lurasidone was associated with significant week 6 changes vs. placebo in both the YMRS irritability item (-1.4 vs. -0.3, p = 0.0012, ES = 1.0) and the YMRS disruptive-aggressive item (-1.0 vs. -0.3, p = 0.0002, ES = 1.2).Conclusions. In our post-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.

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Lurasidone in the Treatment of Acute Schizophrenia

Abstract: (ClinicalTrials.gov) Identifier: NCT00088634.

Cited by 183 publications

References 0 publications

A 6-week, double-blind, placebo- and haloperidol-controlled, phase II study of lurasidone in patients with acute schizophrenia

A 6-week, double-blind, placebo- and haloperidol-controlled, phase II study of lurasidone in patients with acute schizophrenia

New drugs: Lurasidone for schizophrenia

Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis

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