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Lurasidone Hydrochloride for Bipolar Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Lurasidone Hydrochloride for Bipolar Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines | CADTH Skip to main content * About * Collaboration/Outreach * Patient/Community * Careers * Contact * My CADTH * FR * Reports * Reports . Lurasidone Hydrochloride for Bipolar Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines Copied to clipboard Lurasidone Hydrochloride for Bipolar Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines ( Last Updated : February 26, 2020) Project Line: Health Technology Review Project Sub Line: Summary with Critical Appraisal Project Number: RC1244-000
NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior: a randomized prospective phase 2 trial. We tested the hypothesis that, after initial improvement with intravenous ketamine in patients with bipolar disorder (BD) with severe depression and acute suicidal thinking or behavior, a fixed-dose combination of oral D-cycloserine (DCS) and lurasidone (NRX-101) can maintain improvement more effectively than lurasidone alone. This was a multi-center, double-blind, twostage, parallel randomized trial. Adult BD patients with depression and suicidal ideation or behavior were infused with ketamine or saline (Stage 1); those who improved were randomized
Real-world Effectiveness and Tolerability of Lurasidone in Outpatients with Bipolar DisorderII- A 24 week retrospective study (RETLO-BDIIstudy). We conducted a retrospective study to investigate the efficacy and safety of lurasidone (LUR) in outpatients with depressive episodes of bipolar disorder II (BD2) in real world setting. We retrospectively analyzed the clinical data obtained from
Genetic markers of early response to lurasidone in acute schizophrenia. Prediction of treatment response by genetic biomarkers has potential for clinical use and contributes to the understanding of pathophysiology and drug mechanism of action. The purpose of this study is to detect genetic biomarkers possibly associated with response to lurasidone, during the first four weeks of treatment. One -hundred and seventy-one acutely psychotic patients from two placebo-controlled clinical trials of lurasidone were included. Genetic associations with changes in Positive and Negative Syndrome Scale total score at weeks one, two, and four were examined. Genotyping was done with the Affymetrix 6.0 microarray and associations were computed using PLINK regression model. Although genome-wide significance
Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode: A Post Hoc Analysis of 2 Placebo-Controlled Trials. The aim of this study was to compare the efficacy and safety profile of lurasidone combined with either lithium or valproate, in the short-term treatment of patients with bipolar depression. Data were pooled from two 6-week, double-blind, placebo-controlled trials of patients with bipolar depression on stable doses of lithium or valproate randomized to lurasidone (20-120 mg/d) or placebo. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale, Clinical Global Impressions Bipolar Scale, and the Quick Inventory of Depressive Symptomatology via self-assessment and were analyzed using
Valuable interaction with cognitive remediation and optimal antipsychotics for recovery in schizophrenia (VICTORY-S): study protocol for an interventional, open-label, randomized comparison of combined treatment with cognitive remediation and lurasidone Cognitive impairment, a core feature of schizophrenia, is associated with poor outcomes. Pharmacotherapy and psychosocial treatment, when used alone, have inadequate effect sizes for cognitive impairment, leading to recent interest in combination interventions. A previous study examined the additive effect of cognitive remediation on lurasidone in patients with schizophrenia, which was negative. Although improvement in cognitive function was suggested for lurasidone, it was inconclusive because there was no antipsychotic control in the study
Rash caused by lurasidone in old chinese patient with bipolar disorder: case-based review. Rash is one of common adverse drug reaction and which have been reported in typical and atypical antipsychotics. Reports of lurasidone induced skin reactions are sparse. In this study, we report a case of rash caused by lurasidone. A 63-year-old man with bipolar disorder (BD) who is treated by lurasidone . However, the patient presents a rash all over after lurasidone dose increasing from 40 mg/day to 60 mg/day. With the diagnosis of drug induced rash, lurasidone was discontinued, and the rash complete disappears within 2 weeks. In addition, all case reports about antipsychotics associated rash were reviewed by searching English and Chinese database including Pubmed, Embase, Cochrane Library, CNKI
Effect of Lurasidone on Social Functioning in Schizophrenia: Post Hoc Analysis of the JEWEL Study. To evaluate the effects of lurasidone on social functioning in schizophrenia over the course of a 6-week, double-blind, placebo-controlled study and a subsequent 12-week open-label extension study. A total of 478 patients with schizophrenia (per criteria) randomized to either lurasidone 40 mg/d (n = 245) or placebo (n = 233) in the initial 6-week double-blind study (initiated May 2016, completed November 2018) were included in the analysis. Longer-term changes were examined in a sample of 146 patients who received lurasidone, and 141 who received placebo, during the 6-week study and received flexibly dosed (40-80 mg/d) lurasidone during the 12-week extension phase. The 4-item Positive
Efficacy and Safety of Dose Increase From 40 mg/d to 80 mg/d of Lurasidone in Patients With Schizophrenia: A Post Hoc Analysis of Extension Trial. The primary objective of this study was to evaluate the efficacy and safety of increasing the dose of lurasidone from 40 mg/d to 80 mg/d in patients with schizophrenia. This post hoc analysis focused on patients who completed a 6-week double-blind , placebo-controlled trial of lurasidone and transitioned to a subsequent 12-week open-label extension trial. Patients initially assigned to lurasidone (40 mg/d) or placebo during the double-blind trial (DBT-LUR group or DBT-PLA group, respectively) received lurasidone (40 mg/d) during the extension. Clinicians could increase the dose to 80 mg/d based on clinical judgment. The efficacy outcomes included
Schizophrenia: lurasidone Schizophrenia: lurasidone Evidence summary Published: 23 September 2014 www.nice.org.uk/guidance/esnm48 pathwaysThis advice replaces ESNM15. Key points from the evidence Key points from the evidence The content of this evidence summary was up-to-date in September 2014. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Summary Summary Lurasidone (Latuda, Sunovion Pharmaceuticals Europe Ltd) is licensed for treating schizophrenia in adults aged 18 years and over. It was launched in the UK in August 2014. Evidence from 5 short-term and 3 long-term studies suggests that lurasidone is effective at treating psychotic symptoms, and at preventing relapse in adults with schizophrenia
A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Kato et al. reported results of a 6-week, double-blind, randomized, placebo-controlled trial of lurasidone in adults with bipolar depression (BDep). We performed a post hoc analysis using data from the lurasidone trial to predict later responses from early improvements. An early . The interpretation of sensitivity and NPV in the lurasidone group when remission is an outcome is as follows. It means (1) that, from all remitters at Week 6, 80.6% was identified as such at Week 2 on the basis of their early improvement and (2) that a patient showing non-improvement at 2 weeks had 93.5% probability of being a non-remitters at Week 6. However, the values of specificity for both response
Lurasidone Augmentation of Clozapine in Refractory Schizophrenia: A Case Series. Clozapine represents the criterion standard therapy for patients with treatment-resistant schizophrenia. Unfortunately, a significant percentage of such patients are also partial responders to clozapine. Consequently, several augmentation strategies have been proposed with various and sometimes controversial efficacy. Among these add-on treatments, lurasidone has been recently introduced and could represent a potential option, especially for the additional positive effect on cognitive symptoms. This case series aims to determine possible advantages of lurasidone augmentation in four patients treated with clozapine, who were diagnosed with treatment-resistant schizophrenia. Positive and Negative Syndrome
The efficacy and safety of lurasidone in bipolar I depression with and without rapid cycling: A pooled post-hoc analysis of two randomized, placebo-controlled trials. The efficacy and safety of lurasidone monotherapy in patients with bipolar I depression with or without rapid cycling has not been previously investigated. We performed subgroup analysis (rapid cycling/non-rapid cycling) of pooled data from two 6-week, randomized, double-blind, placebo-controlled trials of lurasidone monotherapy (20-60 mg/day or 80-120 mg/day). Analyses included mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Safety assessments included the number of treatment-emergent adverse events (TEAEs) and laboratory assessments. Of 1024 patients randomized, 85 were
Lurasidone and risk of metabolic syndrome: results from short and long-term studies in patients with bipolar depression. The elevated prevalence of metabolic syndrome (MetS) in patients with depression has been associated with increased mortality. This post hoc analysis assessed the effect of treatment with lurasidone on risk of MetS in patients with bipolar depression. Data used in the current -controlled, adjunctive therapy study with lurasidone (N = 490). MetS was defined based on NCEP ATP III criteria (2005 revision). The proportion of patients with new-onset MetS was similar for lurasidone vs placebo in the short-term studies (monotherapy, 13.9% vs 15.3%; adjunctive therapy, 13.6% vs 11.0%); and remained stable during both the 6-month extension phase study (monotherapy, 15.2%; adjunctive
The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. To assess the effects of lurasidone on anxiety symptoms and sleep disruption, and their moderating and mediating roles on treatment response in bipolar depression. This post hoc analysis included pooled data from 2 previously published 6-week placebo-controlled trials of lurasidone (72.1%) experienced baseline sleep disturbance. Lurasidone, as monotherapy (20-60 mg/d and 80-120 mg/d pooled dose groups vs placebo) and adjunctive therapy (20 to 120 mg/d flexibly dosed vs placebo) with lithium or valproate, significantly reduced HAM-A psychic anxiety (-4.82 vs -2.97, .001, monotherapy; -5.56 vs -4.26, .009, adjunctive therapy) and somatic anxiety (-1.89 vs -1.37, .048, monotherapy
Lurasidone - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Lurasidon – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 January 2015). Please note: This translation is provided as a service by IQWiG to English-language readers . However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A14-42 Lurasidone – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A14 -42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i
Effectiveness and Tolerability of Lurasidone for Bipolar Types I and II and Other Specified Bipolar Depression: A 12-Week Observational Study. There are few guidelines on the management of depressive episodes in patients with bipolar type II (BDII) and related disorders (other specified bipolar and related disorders [OSBD]). Lurasidone is a potential option for treating depressive episodes in BDII/OSBD. This retrospective chart review study aimed to examine the effectiveness and tolerability of lurasidone for use in patients with bipolar depression. We reviewed 66 consecutive outpatients with bipolar depression who were prescribed lurasidone between June 2020 and January 2021 and examined 12-week outcomes. Fourteen patients were diagnosed with BDI, and 52 patients were diagnosed with BDII
Efficacy and safety of lurasidone in schizophrenia: pooled analysis of European results from double-blind, placebo-controlled 6-week studies. The objective of this study is to confirm the efficacy and safety of lurasidone in the acute treatment of schizophrenia in European patients. Data were pooled from three studies of patients randomized to 6 weeks of double-blind, placebo-controlled, fixed -dose (40/80 mg and 120/160 mg) lurasidone. The primary efficacy endpoint was a week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score and secondary endpoints included the Clinical Global Impression, Severity scale (CGI-S). In total 328 safety patients were enrolled; 72.6% were completers. Endpoint change was significantly greater in patients treated with 40-80 mg/d and 120-160