Efficacy Of Lurasidone Research Articles

The Role of Lurasidone in Managing Depressive Symptoms in People with Schizophrenia: A Review.

Schizophrenia is a severe mental disorder characterized by positive, negative, affective, and cognitive symptoms. Affective symptoms in patients with schizophrenia have traditionally been overlooked or even neglected because they are not considered as fundamental as positive and negative symptoms in the choice of medication. This paper aims to systematically evaluate the efficacy and safety of lurasidone in the treatment of depressive symptoms of schizophrenia. Lurasidone appears to be particularly effective on the depressive symptomatology of schizophrenia while also alleviating the positive and negative symptoms associated with the illness. The efficacy of lurasidone in treating patients with first-episode psychosis who present with predominant depressive symptoms suggests that this medication may be a valuable treatment option not only for established cases of schizophrenia but also for individuals in the early stages of the illness. The good tolerability of lurasidone is an important factor that may positively influence treatment decisions.

Post-psychotic depression in dual psychosis – efficacy of lurasidone

Post-psychotic depression in dual psychosis – efficacy of lurasidone

P.0552 The early therapeutic efficacy of lurasidone in a rodent model of depression: a behavioural and biomolecular study

P.0552 The early therapeutic efficacy of lurasidone in a rodent model of depression: a behavioural and biomolecular study

Using Lurasidone in the treatment of mental illness in childhood

Lurasidone is one of the newest antipsychotics approved for use in childhood. The review presents generalized data on the pharmacological profile of Lurasidone, preclinical and clinical studies of the drug with an analysis of the parameters of pharmacodynamics, pharmacokinetics, clinical efficacy, tolerability and safety of therapy for schizophrenia and bipolar disorder in children. It also provides data on the off-lable use of Lurasidone in childhood for autism spectrum disorders, Tourette's syndrome, hypomania in the structure of bipolar affective disorder. The data on the efficacy of Lurasidone in a wide range of psychopathological disorders, including positive, negative, affective and cognitive domains, as well as a favorable tolerability profile of the drug, including long-term therapy, are presented.

159 Safety and Efficacy of Lurasidone in Children and Adolescents with Bipolar Depression: Results from a 2-Year Open-label Extension Study

Bipolar I disorder frequently has an early onset, with an estimated prevalence rate of 1.8% in pediatric populations. Early onset is associated with a high degree of chronicity; however, limited data are available on the long-term efficacy of drug therapies in pediatric populations. The aim of the current study was to evaluate the long-term safety and efficacy of lurasidone in children and adolescents with bipolar depression. Patients 10-17 years with bipolar I depression were randomized to 6 weeks of double-blind (DB) treatment with lurasidone or placebo. Patients who completed the study were eligible to enroll in a 2-year, open-label (OL) extension study in which patients were continued on flexibly-dosed lurasidone (20-80 mg/d; LUR-LUR) or switched from placebo to lurasidone (PBO-LUR). The primary efficacy measure was the Children's Depression Rating Scale, Revised (CDRS-R); response was defined as ≥50% reduction from DB baseline in the CDRS-R total score. A total of 306 patients completed the 6-week DB study and entered the extension study; 195 (63.7%) completed 52 weeks, and 168 (54.9%) completed 104 weeks of treatment. Mean CDRS-R total score at DB baseline was 59.4 in patients treated with lurasidone, and 58.7 in patients treated with placebo; and mean CDRS-R total score at OL baseline (after 6 weeks of DB treatment) was 36.6 in the LUR-LUR group and 41.9 in the PBO-LUR group. For the total sample of patients in the OL study, mean change (from OL baseline) in the CDRS-R score was -13.4 at week 52 and -16.4 at week 104; and responder rates were 51.0% at OL baseline (64.5% for LUR-LUR; 36.9% for PBO-LUR), 88.4% at week 52, and 91.1% at week 104. During OL treatment with lurasidone, 31 patients (10.1%) discontinued due to an adverse event. The most commonly reported events were headache (23.9%), nausea (16.4%), and somnolence (9.8%). OL treatment with lurasidone was associated with few effects on metabolic parameters or prolactin. Mean change from DB baseline in weight was +4.25 kg at week 52 (vs. an expected weight gain of 3.76 kg based on CDC normative data), and +6.75 kg at week 104 (vs. CDC expected weight gain of 6.67 kg). Two years of treatment with lurasidone in children and adolescents with bipolar depression was generally well-tolerated, with relatively low rates of study discontinuation. Lurasidone treatment was associated with few effects on weight, metabolic parameters, and prolactin. Patients also continued to experience improvement in depressive symptoms during long-term treatment with lurasidone.Clinicaltrials.gov identifier: NCT01914393. Supported by funding from Sunovion Pharmaceuticals Inc.

Randomized, double-blind, placebo, and risperidone-controlled study of lurasidone in the treatment of schizophrenia: Results of an inconclusive 6-week trial.

The efficacy and safety of lurasidone in schizophrenia has been demonstrated in multiple controlled trials, primarily in US and European populations. The aim of the current study was To evaluate lurasidone for the treatment of schizophrenia among patients in Japan, Korea, and Taiwan. Hospitalized patients (N=460) with schizophrenia were randomized to 6weeks of fixed-dose lurasidone 40mg/d, lurasidone 80mg/d, risperidone 4mg/d, or placebo. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S). No significant endpoint differences in PANSS total score were found for lurasidone or risperidone vs placebo. Lurasidone was safe and well tolerated, with minimal effects on weight and metabolic parameters. The current study was inconclusive regarding the efficacy of lurasidone in schizophrenia but further confirmed its safety and tolerability.

1.5 Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar Depression: Interim Analysis of a Two-Year Open-Label Extension Study

The goal of this session is to evaluate the long-term safety and efficacy of lurasidone in children and adolescents with bipolar depression.

6.29 Efficacy of Lurasidone in Child and Adolescent Patients With Bipolar Depression and Anxiety: A Post-Hoc Analysis

6.29 Efficacy of Lurasidone in Child and Adolescent Patients With Bipolar Depression and Anxiety: A Post-Hoc Analysis

Efficacy of lurasidone in the treatment of agitation: A post hoc analysis of five short-term studies in acutely ill patients with schizophrenia.

This post hoc analysis evaluated the effect of lurasidone on agitation in acutely ill patients with schizophrenia. Patient-level data were pooled from five 6-week, randomized, double-blind, placebo-controlled studies of fixed-dose, once-daily, oral lurasidone (40, 80, 120, or 160 mg/d). Agitation was assessed with the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score, utilizing a mixed model for repeated measurement analysis. In patients with higher levels of agitation at baseline (PANSS-EC score≥14; n=773), lurasidone was associated with significantly greater improvement in least-squares (LS) mean PANSS-EC scores versus placebo at Day 3/4 (-1.6 vs -1.0; p<0.05), Day 7 (-2.3 vs -1.6; p<0.05), and at Week 6 endpoint (-5.5 vs -3.8; p<0.001; effect size=0.43). In patients with lower agitation at baseline (PANSS-EC score<14; n=754), LS mean PANSS-EC score change was significantly greater for lurasidone compared with placebo at Day 7 (-0.8 vs -0.1; p<0. 01) through Week 6 endpoint (-1.9 vs -0.9; p<0.001; effect size=0.31). Higher doses of lurasidone were notably more effective than lower doses in patients with more severe agitation at study baseline. In this pooled analysis of 5 short-term studies, lurasidone provided early and sustained reduction in agitation, assessed using the PANSS-EC score, in patients with an acute exacerbation of schizophrenia. Higher doses of lurasidone were particularly effective in patients with more severe agitation at study baseline. Overall, these results suggest that lurasidone may be a useful treatment option for patients exhibiting agitation associated with acute psychotic symptoms of schizophrenia. ClinicalTrials.gov Identifiers: NCT00088634 (Study D1050196); NCT00549718 (Study D1050229), NCT00615433 (Study D1050231); NCT00790192 (Study D1050233). Study D1050006 was completed prior to the requirement to register trials.

Lurasidone for the treatment of major depressive disorder with mixed features: Do manic symptoms moderate treatment response?

BackgroundThis post-hoc analysis evaluated whether the efficacy of lurasidone in major depressive disorder (MDD) with mixed features is moderated by the number and characteristics of manic symptoms present at study baseline.MethodsPatients meeting DSM-IV-TR criteria for MDD who presented with two or three manic symptoms (consistent with the DSM–5 mixed features specifier) were randomly assigned to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/d (n = 109) or placebo (n = 100). Finite mixture models were applied to identify latent class patterns of the 10 baseline manic symptoms.ResultsThree latent class profiles were identified: 105 (50.5%) patients had manic symptom profile 1 (MIX 1) with mean MADRS 33.0, mean YMRS 9.2, mean number of manic symptoms 3.8; 63 (30.3%) patients had manic symptom profile 2 (MIX 2) with similar baseline mean MADRS (32.4) and YMRS (9.3) and lower number of manic symptoms 3.5; 40 patients had manic symptom profile 3 (MIX 3) with significantly higher severity scores in MADRS (35) and YMRS (14.9) and mean number of manic symptoms 4.6. A significant moderating effect on change in YMRS score was observed for the “decreased need for sleep” symptom, with greater lurasidone effect size (vs. Placebo) found in patients without vs. With this symptom (P &lt; 0.05).ConclusionsIn this post-hoc analysis of a placebo-controlled trial involving MDD patients with mixed features, absence of “decreased need for sleep” was found to be significantly associated with improvement in manic and depressive symptoms and to moderate the treatment effect on manic symptoms.Disclosure of interestI am full time employee of Sunovion pharmaceuticals Inc.

P.2.b.062 - Efficacy of lurasidone in the treatment of major depression with mixed features: the value of early improvement as a predictor of short-term response during treatment of bipolar depression with lurasidone

Sleep profile in bipolar disorder has received little attention in comparison to sleep studies in major depressive disorders. Specific sleep abnormalities especially in REM sleep parameters have been detected in depression. The current study aimed at investigating whether bipolar disorder shares the same polysomnographic (PSG) changes or not.All night polysomnographic assessments were made for 20 patients diagnosed to have hypomania, in addition to 20 patients with major depression and 20 healthy matched controls. All participants were examined using Standardized Sleep Questionnaire, SCID-I for psychiatric diagnosis, based on DSM-IV criteria, YMRS (for hypomanic patients), HAMD (for major depression patients), and all-night polysomnography (for all subjects).The two patient groups differed significantly from controls in their sleep profile, especially regarding sleep continuity measures, Short REML (Rapid Eye Movement Latency), with increased REMD (Rapid Eye Movement sleep density). High similarity was found in EEG sleep profile of the two patient groups, though the changes were more robust in patients with depressionA relatively small sample size, the absence of follow up assessment, lack of consideration of other variables like body mass index, nicotine and caffeine intake.Similarity in EEG sleep profile between Bipolar disorder patients and patients with major depression suggests a common biological origin for both conditions, with the difference being “quantitative” rather than “qualitative”. This quantitative difference in sleep efficiency and SWS (Slow wave sleep), being higher in hypomania, might explain the rather “refreshing” nature of sleep in hypomanic patients, compared to depression.

P.3.f.006 - Efficacy of lurasidone in schizophrenia: a systematic review and meta-analysis of short-term trials utilizing active comparator

P.3.f.006 - Efficacy of lurasidone in schizophrenia: a systematic review and meta-analysis of short-term trials utilizing active comparator

P.3.d.057 - Efficacy of lurasidone in patients with schizophrenia with prominent positive symptoms: a pooled analysis of short-term placebo-controlled studies

Terpenoids comprise a large (>55 000) family of compounds, very few of which have been used commercially due to low and economically unpractical production in their native hosts (generally plants and microorganisms). Two examples of natural terpenoid production are described (rubber and astaxanthin), but the advent of metabolic engineering has allowed the development of fermentative production processes using heterologous microorganisms. The two biochemical pathways responsible for terpenoid production are described, along with manipulations that enable production of terpenoids at economically viable levels. Finally, this article reviews some terpenoids that are currently in commercial production or development, ranging from semisynthetic production of the antimalarial drug artemisinin, through fragrance molecules, to commodity chemicals such as isoprene and β-farnesene.

PM418. Efficacy of Lurasidone in Patients With Schizophrenia With Prominent Positive Symptoms: A Pooled Analysis of Short-Term Placebo-Controlled Studies

PM418. Efficacy of Lurasidone in Patients With Schizophrenia With Prominent Positive Symptoms: A Pooled Analysis of Short-Term Placebo-Controlled Studies

Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials.

BackgroundDepressive symptoms associated with bipolar disorder negatively impact health-related quality of life (HRQoL). The efficacy of lurasidone in reducing depressive symptoms has been previously demonstrated. The objective of this study was to examine the direct and indirect effect (mediated through improvement in depression symptoms) of lurasidone in improving patient HRQoL.MethodsA secondary analysis of data was conducted of two 6-week, double-blind, placebo-controlled trials assessing the effect of lurasidone (lurasidone monotherapy [20–60 mg/day or 80–120 mg/day]; lurasidone adjunctive to lithium or valproate [20–120 mg/day]) in patients with bipolar depression. Patient HRQoL was measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). Depression symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of covariance (ANCOVA) was used to estimate the effect of lurasidone on improvement in the Q-LES-Q SF percentage maximum score from baseline to 6 weeks. Path analysis was used to evaluate the total effect (β1), as well as the indirect (β2*β3) and direct (β4) effect of lurasidone on Q-LES-Q SF change through improvements in MADRS.ResultsA total of 340 and 485 patients from the monotherapy and adjunctive therapy, respectively, were included in the analysis. At 6-weeks, ANCOVA analyses demonstrated that lurasidone provided significant improvement in adjusted mean Q-LES-Q SF scores in comparison to placebo for monotherapy (22.9 and 22.7 vs. 15.2, both p < 0.01) and adjunctive therapy (23.1 vs. 17.9, p = 0.01). Path analyses indicated that lurasidone treatment predicted MADRS improvement (monotherapy: β2 = −0.44, p < 0.001; adjunctive therapy: β2 = −0.34, p = 0.003), which subsequently predicted improvement in Q-LES-Q SF (monotherapy: β3 = −0.73, p < 0.001; adjunctive therapy: β3 = −0.75, p < 0.001); however, the effect of lurasidone on improvement in Q-LES-Q SF was largely mediated by change in MADRS (monotherapy: β4 = 0.11, p = 0.13; adjunctive therapy: β4 = 0.02, p = 0.77).ConclusionsLurasidone as a monotherapy and adjunctive to lithium or valproate is an effective treatment for improving HRQoL in patients with bipolar depression. However, improvement in HRQoL was not independent of improvement in depression, indicating that the effect of lurasidone on improving patient HRQoL may act through a reduction in depressive symptoms associated with bipolar disorder.Trial registrationClinicaltrials.gov identifiers: NCT00868699 and NCT00868452 (both registered March 23, 2009)

Efficacy of lurasidone in major depression with mixed features: Pattern of improvement in depressive and manic symptoms

IntroductionEvidence indicates that manic symptoms, below the threshold for hypomania (mixed features), are common in individuals with major depressive disorder (MDD).Objectives/aimsTo evaluate the effect of lurasidone on specific depressive and manic symptoms, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) items, in patients with MDD with mixed features.MethodsPatients meeting DSM-IV-TR criteria for MDD, who presented with 2–3 protocol-specified manic symptoms, were randomized to 6 weeks of double-blind treatment with lurasidone monotherapy 20–60 mg/d (n = 109) or placebo (n = 100). Change from baseline in the MADRS total, MADRS-6 core depression subscale, individual MADRS items, and total and individual items of the YMRS were analyzed by MMRM, and Cohen's d effect sizes (d) were calculated for week 6 change scores.ResultsLurasidone improved depressive symptoms at week 6 in the MADRS total score (–20.5 vs. –13.0; P &lt; 0.0001; d = 0.8) and MADRS-6 core depression score (–13.0 vs. –8.5; P &lt; 0.0001; d = 0.7). Significant improvement on lurasidone was observed at week 6 on all ten MADRS items (d = 0.36–0.78). Effect sizes for the MADRS-6 core depression subscale items ranged from 0.36 to 0.78 at week 6. Treatment with lurasidone was associated with significantly greater week 6 improvement on the YMRS (–7.0 vs. –4.9; P &lt; 0.0001). Effect sizes for the 5 YMRS items with baseline item severity ≥ 2 ranged from 0.32 to 0.48.ConclusionsIn this study of MDD with mixed features, lurasidone was effective in treating the range of depressive and manic symptoms that patients presented with.Sponsored by Sunovion Pharmaceuticals Inc.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Effects of Lurasidone On Hostility in Patients with an Acute Exacerbation of Schizophrenia: a Pooled Post HOC Analysis of 5 Short-term Studies

Introduction Lurasidone has demonstrated efficacy in the treatment of schizophrenia. Objective To evaluate the effect of lurasidone on hostility in patients with an acute exacerbation of schizophrenia. Aims To assess the efficacy of lurasidone for reducing hostility. Methods Data were pooled from 5 double-blind, placebo-controlled, 6-week studies of lurasidone (40-160 mg/d) in patients with evidence of hostility at study baseline (Positive and Negative Syndrome Scale [PANSS] hostility item score ≥2). Lurasidone was compared with placebo using mixed-model repeated-measures analysis, with and without adjustment for positive symptoms of schizophrenia and somnolence as covariates. Results A total of 1148 patients met criteria for hostility at baseline (lurasidone, n=775; placebo, n=373). Lurasidone was significantly superior to placebo in reducing the PANSS hostility item score from Week 1 (P=0.002) through Week 6 (P>0.001). After adjusting for change in positive symptoms, lurasidone significantly decreased hostility compared with placebo from Week 2 (P=0.014) through Week 6 (P>0.05). After adjusting for the presence of somnolence, lurasidone significantly reduced hostility relative to placebo beginning at Week 2 and every assessment thereafter (P>0.05), except for Week 6. Overall, 63.1% of lurasidone-treated patients demonstrated any improvement (≥1 point change) on the PANSS hostility item at study endpoint compared with 55.0% of patients taking placebo (number needed to treat=13; 95% confidence interval, 8-49). Conclusions Lurasidone showed a specific antihostility effect in this post hoc analysis; improvement in hostility was significantly greater with lurasidone than placebo and was independent of change in other positive symptoms or somnolence. Funding Sunovion Pharmaceuticals Inc.

P.3.d.058 Maintenance efficacy of lurasidone compared to high-dose quetiapine XR in schizophrenia: results from a post-hoc analysis

P.3.d.058 Maintenance efficacy of lurasidone compared to high-dose quetiapine XR in schizophrenia: results from a post-hoc analysis

P.3.d.060 Efficacy of lurasidone in the treatment of schizophrenia with prominent negative symptoms: a post-hoc analysis of five short-term trials

P.3.d.060 Efficacy of lurasidone in the treatment of schizophrenia with prominent negative symptoms: a post-hoc analysis of five short-term trials

EPA-0423 - Efficacy of lurasidone in the treatment of agitation associated with acute schizophrenia

Introduction Agitation is a common presentation among patients hospitalized for an acute exacerbation of schizophrenia. Rapid and effective control of agitation is an important early treatment goal. Objectives The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in reducing agitation in patients with an acute exacerbation of schizophrenia. Methods The analysis was performed on pooled data from 5 six-week, placebo-controlled trials in the subgroup of patients with an acute exacerbation of schizophrenia who met (n=773), or did not meet (n=754), criteria) for agitation (PANSS-Excited Component [EC] score ≥14 at baseline, Citrome, J Clin Psych 2007;68:1876-1885). Patients were randomized to fixed once-daily doses of lurasidone (40-160 mg). Results The mean baseline PANSS-EC scores were similar for lurasidone vs. placebo in the high (16.7 vs. 16.8) and low (10.9 vs. 10.7) agitation subgroups. In the high agitation subgroup, treatment with lurasidone (vs. placebo) was associated with significantly greater improvement in PANSS-EC scores at days 3/4 (-2.0 vs. -1.3; p Conclusions In this pooled post-hoc analysis, treatment with lurasidone significantly reduced agitation by day 3/4 in patients hospitalized with an acute exacerbation of schizophrenia. The magnitude of improvement at week 6 was similar in both the high and low agitation groups.