BACKGROUND First-generation antipsychotics demonstrate certain therapeutic benefits in schizophrenia;however,they often fail to significantly address negative symptoms.Thus,continued exploration is essential to refine...BACKGROUND First-generation antipsychotics demonstrate certain therapeutic benefits in schizophrenia;however,they often fail to significantly address negative symptoms.Thus,continued exploration is essential to refine these treatments.AIM To examine lurasidone plus sulpiride influence on treatment efficacy,psychiatric symptoms,and quality of life in patients with schizophrenia.METHODS A total of 110 patients with schizophrenia,admitted between October 2021 and October 2024,were recruited for this study.The control group(n=50)received sulpiride alone.Conversely,the observation group(n=60)was treated with a combination of lurasidone and sulpiride.A series of assessments were conducted to compare the two groups.These included evaluating treatment efficacy;recording the incidence of adverse events such as fatigue,xerostomia,insomnia,anorexia,and headache;assessing psychiatric symptoms using the positive and negative syndrome scale(PANSS);evaluating cognitive and social functions using the repeatable battery for the assessment of neuropsychological status(RBANS),and the personal and social performance scale(PSP);measuring quality of life using the schizophrenia quality of life scale(SQLS);and analyzing serum markers including interleukin 6(IL-6),IL-17,and prolactin(PRL).RESULTS Overall treatment efficacy was significantly higher in the observation group than in the control group.The total incidence of adverse events was comparable between the two groups.After treatment,the scores for positive symptoms,negative symptoms,and general psychopathological symptoms on the PANSS in the observation group were significantly reduced compared to pretreatment levels,and were also lower than those in the control group.Additionally,RBANS and PSP scores in the observation group significantly increased post-treatment and were notably higher than in the control group.Regarding the quality of life,SQLS scores in the psychosocial,symptoms,and side effects and motivation and energy dimensions in the observation group were significantly lower after treatment than both baseline levels and those in the control group.Furthermore,post-treatment levels of IL-6 and IL-17 in the observation group were significantly reduced and lower than those in the control group,whereas the PRL level was significantly elevated.CONCLUSION The combination of lurasidone and sulpiride can effectively enhance treatment efficacy,alleviate psychiatric symptoms,and improve quality of life in patients with schizophrenia,supporting its broader clinical use.展开更多
BACKGROUND Schizophrenia,a complex group of mental disorders,is primarily managed with antipsychotic medications.The safety and efficacy of different initial doses of lurasidone for acute schizophrenia remain uncertai...BACKGROUND Schizophrenia,a complex group of mental disorders,is primarily managed with antipsychotic medications.The safety and efficacy of different initial doses of lurasidone for acute schizophrenia remain uncertain,particularly concerning discontinuation rates due to adverse events(AEs).AIM To compare the safety of two initial doses of lurasidone for the treatment of acute schizophrenia in Chinese patients.METHODS This 6-week,randomized,open-label,multicenter trial allocated participants to receive either 40 mg/day or 80 mg/day lurasidone initially,with dose adjustment allowed after a one-week fixed-dose period.Safety assessments included the primary endpoint of discontinuation due to AEs,as well as evaluations of AEs,weight changes,and laboratory parameters.Efficacy assessments included responder rates and changes in scores on the Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Severity scale,and Calgary Depression Scale for Schizophrenia.RESULTS Among 197 participants,no significant difference was found in discontinuation rate due to AEs between groups(3.03% vs 5.10%,P=0.707).Treatment-emergent AEs were reported in 64.6%and 71.4%of participants in the 40 mg/day and 80 mg/day initiation groups,respectively.Response rates at weeks 1 and 2 showed no statistically significant differences.Both groups demonstrated significant improvements in PANSS total,Clinical Global Impression-Severity,and Calgary Depression Scale for Schizophrenia scores from baseline(all P<0.01).Notably,the 80 mg/day initiation group showed greater improvement in the PANSS positive subscale score at visits 1 and 2 compared to the 40 mg/day initiation group(P<0.05).CONCLUSION Initial doses of 40 mg/day and 80 mg/day lurasidone are safe and effective for acute schizophrenia,with no significant increase in AEs-related discontinuation rate at the higher dose.展开更多
BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 m...BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/d.However,post-market surveillance(PMS)with an adequate sample size is required for further validation of the drug’s safety profile and effectiveness.AIM To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese population.METHODS A prospective,multicenter,open-label,12-wk surveillance was conducted in China's Mainland.All patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for enrollment.Safety assessments included adverse events(AEs),adverse drug reactions(ADRs),extrapyramidal symptoms(EPS),akathisia,use of EPS drugs,weight gain,and laboratory values as metabolic parameters and the QTc interval.The effectiveness was assessed using the brief psychiatric rating scale(BPRS)from baseline to the end of treatment.RESULTS A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim analysis.The average daily dose was 61.7±19.08 mg(mean±SD)during the treatment.AEs and ADRs were experienced by 101 patients(11.3%)and 78 patients(8.7%),respectively,which were mostly mild.EPS occurred in 25 individuals with a 2.8%incidence,including akathisia in 20 individuals(2.2%).Moreover,59 patients received drugs for treating EPS during the treatment,with an incidence of 6.6%which dropped to 5.4%at the end of the treatment.The average weight change was 0.20±2.36 kg(P=0.01687)with 0.8%of patients showing a weight gain of≥7%at week 12 compared with that at the baseline.The mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal ranges.The mean changes in total BPRS scores were-8.9±9.76(n=959),-13.5±12.29(n=959),and-16.8±13.97(n=959)after 2/4,6/8,and 12 wk,respectively(P<0.001 for each visit compared with the baseline)using the last-observation-carried-forward method.CONCLUSION The interim analysis of the PMS of adult patients with schizophrenia demonstrate the safety and effectiveness of lurasidone in the Chinese population.No new safety or efficacy concerns were identified.展开更多
BACKGROUND Tardive sensory syndrome(TSS)is a subtype of tardive syndrome(TS),and its etiology is still uncertain.Lurasidone is an atypical antipsychotic that has high affinity for dopamine D2-and serotonergic 5HT2A-an...BACKGROUND Tardive sensory syndrome(TSS)is a subtype of tardive syndrome(TS),and its etiology is still uncertain.Lurasidone is an atypical antipsychotic that has high affinity for dopamine D2-and serotonergic 5HT2A-and 5-HT7-receptors.CASE SUMMARY A 52-year-old woman,previously diagnosed with schizophrenia,and with no history of movement disorders and no sensory paresthesia,had taken lurasidone,initiate dose 40 mg daily then up titration to 120 mg daily,since March 2021,and developed mandibular sensory(pain)paresthesia after 3 mo of administration.After switching from lurasidone to quetiapine,she reported obvious improvement in her mandibular pain.CONCLUSION It is noteworthy that TSS is a rare subtype of TS,and lurasidone,an atypical antipsychotic,usually has a lower risk of causing TS.In light of the temporal relationship,it is therefore concluded that use of lurasidone might have caused TSS in this patient.We reported this rare case as a reminder that clinicians should adopt a cautious approach when prescribing atypical antipsychotics,so as to prevent TS.展开更多
Objective:Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial.This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression....Objective:Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial.This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression.Methods:Patients with bipolarⅡdepression were enrolled in this prospective,two-center,randomized,12-week pilot trial.The main indicator for assessing treatment effectiveness was a Montgomery-Asberg Depression Rating Scale(MADRS)of≥50%.All eligible patients initially received four weeks of lurasidone monotherapy.Patients who responded well continued to receive this kind of monotherapy.However,no-response patients were randomly assigned to either valproate or vortioxetine treatment for eight weeks.By comprehensively comparing the results of MADRS over a period of 4-12 weeks,a systematic analysis was conducted to determine whether vortioxetine could be used as an adjuvant drug for treating bipolar depression.Results:Thirty-seven patients responded to lurasidone monotherapy,and 60 patients were randomly assigned to the valproate or vortioxetine group for eight weeks.After two weeks of combined valproate or vortioxetine treatment,the MADRS score in the vortioxetine group was significantly lower than that in the valproate group.There was no difference in the MADRS scores between the two groups at 8 and 12 weeks.The incidence of side effects did not significantly differ between the valproate and vortioxetine groups.Importantly,three patients in the vortioxetine group appeared to switch to mania or hypomania.Conclusions:This study suggested that lurasidone combination with vortioxetine might have potential benefits to bipolar II depression in the early stage,while disease progression should be monitored closely for the risk of switching to mania.展开更多
文摘BACKGROUND First-generation antipsychotics demonstrate certain therapeutic benefits in schizophrenia;however,they often fail to significantly address negative symptoms.Thus,continued exploration is essential to refine these treatments.AIM To examine lurasidone plus sulpiride influence on treatment efficacy,psychiatric symptoms,and quality of life in patients with schizophrenia.METHODS A total of 110 patients with schizophrenia,admitted between October 2021 and October 2024,were recruited for this study.The control group(n=50)received sulpiride alone.Conversely,the observation group(n=60)was treated with a combination of lurasidone and sulpiride.A series of assessments were conducted to compare the two groups.These included evaluating treatment efficacy;recording the incidence of adverse events such as fatigue,xerostomia,insomnia,anorexia,and headache;assessing psychiatric symptoms using the positive and negative syndrome scale(PANSS);evaluating cognitive and social functions using the repeatable battery for the assessment of neuropsychological status(RBANS),and the personal and social performance scale(PSP);measuring quality of life using the schizophrenia quality of life scale(SQLS);and analyzing serum markers including interleukin 6(IL-6),IL-17,and prolactin(PRL).RESULTS Overall treatment efficacy was significantly higher in the observation group than in the control group.The total incidence of adverse events was comparable between the two groups.After treatment,the scores for positive symptoms,negative symptoms,and general psychopathological symptoms on the PANSS in the observation group were significantly reduced compared to pretreatment levels,and were also lower than those in the control group.Additionally,RBANS and PSP scores in the observation group significantly increased post-treatment and were notably higher than in the control group.Regarding the quality of life,SQLS scores in the psychosocial,symptoms,and side effects and motivation and energy dimensions in the observation group were significantly lower after treatment than both baseline levels and those in the control group.Furthermore,post-treatment levels of IL-6 and IL-17 in the observation group were significantly reduced and lower than those in the control group,whereas the PRL level was significantly elevated.CONCLUSION The combination of lurasidone and sulpiride can effectively enhance treatment efficacy,alleviate psychiatric symptoms,and improve quality of life in patients with schizophrenia,supporting its broader clinical use.
文摘BACKGROUND Schizophrenia,a complex group of mental disorders,is primarily managed with antipsychotic medications.The safety and efficacy of different initial doses of lurasidone for acute schizophrenia remain uncertain,particularly concerning discontinuation rates due to adverse events(AEs).AIM To compare the safety of two initial doses of lurasidone for the treatment of acute schizophrenia in Chinese patients.METHODS This 6-week,randomized,open-label,multicenter trial allocated participants to receive either 40 mg/day or 80 mg/day lurasidone initially,with dose adjustment allowed after a one-week fixed-dose period.Safety assessments included the primary endpoint of discontinuation due to AEs,as well as evaluations of AEs,weight changes,and laboratory parameters.Efficacy assessments included responder rates and changes in scores on the Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Severity scale,and Calgary Depression Scale for Schizophrenia.RESULTS Among 197 participants,no significant difference was found in discontinuation rate due to AEs between groups(3.03% vs 5.10%,P=0.707).Treatment-emergent AEs were reported in 64.6%and 71.4%of participants in the 40 mg/day and 80 mg/day initiation groups,respectively.Response rates at weeks 1 and 2 showed no statistically significant differences.Both groups demonstrated significant improvements in PANSS total,Clinical Global Impression-Severity,and Calgary Depression Scale for Schizophrenia scores from baseline(all P<0.01).Notably,the 80 mg/day initiation group showed greater improvement in the PANSS positive subscale score at visits 1 and 2 compared to the 40 mg/day initiation group(P<0.05).CONCLUSION Initial doses of 40 mg/day and 80 mg/day lurasidone are safe and effective for acute schizophrenia,with no significant increase in AEs-related discontinuation rate at the higher dose.
基金Collaborative Innovation Center Project of Translational Medicine,Shanghai Jiaotong University School of Medicine,No.TM202116PT(2021-2023)Clinical Research Plan of SHDC,No.SHDC2022CRS032and the Sumitomo Pharmaceuticals(Suzhou)Co.,Ltd.
文摘BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/d.However,post-market surveillance(PMS)with an adequate sample size is required for further validation of the drug’s safety profile and effectiveness.AIM To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese population.METHODS A prospective,multicenter,open-label,12-wk surveillance was conducted in China's Mainland.All patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for enrollment.Safety assessments included adverse events(AEs),adverse drug reactions(ADRs),extrapyramidal symptoms(EPS),akathisia,use of EPS drugs,weight gain,and laboratory values as metabolic parameters and the QTc interval.The effectiveness was assessed using the brief psychiatric rating scale(BPRS)from baseline to the end of treatment.RESULTS A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim analysis.The average daily dose was 61.7±19.08 mg(mean±SD)during the treatment.AEs and ADRs were experienced by 101 patients(11.3%)and 78 patients(8.7%),respectively,which were mostly mild.EPS occurred in 25 individuals with a 2.8%incidence,including akathisia in 20 individuals(2.2%).Moreover,59 patients received drugs for treating EPS during the treatment,with an incidence of 6.6%which dropped to 5.4%at the end of the treatment.The average weight change was 0.20±2.36 kg(P=0.01687)with 0.8%of patients showing a weight gain of≥7%at week 12 compared with that at the baseline.The mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal ranges.The mean changes in total BPRS scores were-8.9±9.76(n=959),-13.5±12.29(n=959),and-16.8±13.97(n=959)after 2/4,6/8,and 12 wk,respectively(P<0.001 for each visit compared with the baseline)using the last-observation-carried-forward method.CONCLUSION The interim analysis of the PMS of adult patients with schizophrenia demonstrate the safety and effectiveness of lurasidone in the Chinese population.No new safety or efficacy concerns were identified.
文摘BACKGROUND Tardive sensory syndrome(TSS)is a subtype of tardive syndrome(TS),and its etiology is still uncertain.Lurasidone is an atypical antipsychotic that has high affinity for dopamine D2-and serotonergic 5HT2A-and 5-HT7-receptors.CASE SUMMARY A 52-year-old woman,previously diagnosed with schizophrenia,and with no history of movement disorders and no sensory paresthesia,had taken lurasidone,initiate dose 40 mg daily then up titration to 120 mg daily,since March 2021,and developed mandibular sensory(pain)paresthesia after 3 mo of administration.After switching from lurasidone to quetiapine,she reported obvious improvement in her mandibular pain.CONCLUSION It is noteworthy that TSS is a rare subtype of TS,and lurasidone,an atypical antipsychotic,usually has a lower risk of causing TS.In light of the temporal relationship,it is therefore concluded that use of lurasidone might have caused TSS in this patient.We reported this rare case as a reminder that clinicians should adopt a cautious approach when prescribing atypical antipsychotics,so as to prevent TS.
基金partially supported by the Construction Fund of Key Medical Disciplines of Hangzhou(No.OO2020491)the National Key Research and Development Program of China(No.2023YFC2506200)+4 种基金the Zhejiang Provincial Key Research and Development Program(No.2021C03107)the Research Project of Jinan Microecological Biomedicine Shandong Laboratory(No.JNL-2023001B)the Leading Talent of Scientific and Technological Innovation-“Ten Thousand Talents Program”of Zhejiang Province(No.2021R52016)the Innovation Team for Precision Diagnosis and Treatment of Major Brain Diseases(No.2020R01001)the Chinese Medical Education Association(No.2022KTZ004).
文摘Objective:Whether vortioxetine has a utility as an adjuvant drug in the treatment of bipolar depression remains controversial.This study aimed to validate the efficacy and safety of vortioxetine in bipolar depression.Methods:Patients with bipolarⅡdepression were enrolled in this prospective,two-center,randomized,12-week pilot trial.The main indicator for assessing treatment effectiveness was a Montgomery-Asberg Depression Rating Scale(MADRS)of≥50%.All eligible patients initially received four weeks of lurasidone monotherapy.Patients who responded well continued to receive this kind of monotherapy.However,no-response patients were randomly assigned to either valproate or vortioxetine treatment for eight weeks.By comprehensively comparing the results of MADRS over a period of 4-12 weeks,a systematic analysis was conducted to determine whether vortioxetine could be used as an adjuvant drug for treating bipolar depression.Results:Thirty-seven patients responded to lurasidone monotherapy,and 60 patients were randomly assigned to the valproate or vortioxetine group for eight weeks.After two weeks of combined valproate or vortioxetine treatment,the MADRS score in the vortioxetine group was significantly lower than that in the valproate group.There was no difference in the MADRS scores between the two groups at 8 and 12 weeks.The incidence of side effects did not significantly differ between the valproate and vortioxetine groups.Importantly,three patients in the vortioxetine group appeared to switch to mania or hypomania.Conclusions:This study suggested that lurasidone combination with vortioxetine might have potential benefits to bipolar II depression in the early stage,while disease progression should be monitored closely for the risk of switching to mania.
