Background: Long-acting injectable antipsychotics (LAIs) may potentially benefit patients requiring psychiatric hospitalization during the early stages of schizophrenia. However, few studies have compared the long-term effectiveness between patients who switched to LAIs and those who remained on oral antipsychotics (OAPs). Methods: Using the Taiwan National Health Insurance Research Database, we constructed a population-based cohort with 19,813 new OAP users with ICD-9-CM-defined schizophrenia who were hospitalized from 2002 to 2005. Within this cohort, 678 patients who switched to LAIs during their hospitalization were identified. The LAI group was matched to patients who remained on OAPs (n = 678). The LAI cohort was further subdivided for analysis into patients who switched to LAIs within 3 years of OAP initiation ("an early stage") and those who switched after 3 years ("a late stage"). Conditional Cox regressions and conditional negative binomial regressions were used to estimate the risk of death and the number of hospital visits between the two groups. Results: During the 13-year study period, 312 patients switched to LAIs within the first 3 years of OAP initiation. All- and natural-cause mortalities in these patients were significantly lower than in those who remained on OAPs. The hazard ratios (HRs) for all- and natural-cause mortalities were 0.49 (95% confidence interval [CI], 0.27-0.87) and 0.30 (95% CI, 0.15-0.60), respectively. No significant decrease associated with LAIs was observed in unnatural-cause mortality. Patients receiving LAIs had lower risks of rehospitalization (incidence rate ratio [IRR] = 0.56, 95% CI, 0.45-0.69), psychiatric hospitalization (IRR = 0.63, 95% CI, 0.50-0.81), and psychiatric emergency room visits (IRR = 0.58, 95% CI, 0.45-0.75) compared to patients who remained on OAPs. Use of LAIs in the late stage of treatment did not decrease the risk of relapse or mortality. Conclusions: Switching to LAIs during the first 3 years of treatment improved antipsychotic adherence, decreased relapses, and reduced long-term mortality. Our results provide evidence to support the benefits of early LAI treatment in schizophrenia.
{"title":"Long-term Outcomes of Early Use of Long-Acting Injectable Antipsychotics in Schizophrenia.","authors":"S. Fang, Cheng-Yi Huang, Y. J. Shao","doi":"10.4088/jcp.21r14153","DOIUrl":"https://doi.org/10.4088/jcp.21r14153","url":null,"abstract":"Background: Long-acting injectable antipsychotics (LAIs) may potentially benefit patients requiring psychiatric hospitalization during the early stages of schizophrenia. However, few studies have compared the long-term effectiveness between patients who switched to LAIs and those who remained on oral antipsychotics (OAPs).\u0000Methods: Using the Taiwan National Health Insurance Research Database, we constructed a population-based cohort with 19,813 new OAP users with ICD-9-CM-defined schizophrenia who were hospitalized from 2002 to 2005. Within this cohort, 678 patients who switched to LAIs during their hospitalization were identified. The LAI group was matched to patients who remained on OAPs (n = 678). The LAI cohort was further subdivided for analysis into patients who switched to LAIs within 3 years of OAP initiation (\"an early stage\") and those who switched after 3 years (\"a late stage\"). Conditional Cox regressions and conditional negative binomial regressions were used to estimate the risk of death and the number of hospital visits between the two groups.\u0000Results: During the 13-year study period, 312 patients switched to LAIs within the first 3 years of OAP initiation. All- and natural-cause mortalities in these patients were significantly lower than in those who remained on OAPs. The hazard ratios (HRs) for all- and natural-cause mortalities were 0.49 (95% confidence interval [CI], 0.27-0.87) and 0.30 (95% CI, 0.15-0.60), respectively. No significant decrease associated with LAIs was observed in unnatural-cause mortality. Patients receiving LAIs had lower risks of rehospitalization (incidence rate ratio [IRR] = 0.56, 95% CI, 0.45-0.69), psychiatric hospitalization (IRR = 0.63, 95% CI, 0.50-0.81), and psychiatric emergency room visits (IRR = 0.58, 95% CI, 0.45-0.75) compared to patients who remained on OAPs. Use of LAIs in the late stage of treatment did not decrease the risk of relapse or mortality.\u0000Conclusions: Switching to LAIs during the first 3 years of treatment improved antipsychotic adherence, decreased relapses, and reduced long-term mortality. Our results provide evidence to support the benefits of early LAI treatment in schizophrenia.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86972659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Between 0.3%-4.6% of women use antipsychotic (AP) drugs during pregnancy. Two large, retrospective, population-based cohort studies, conducted in Nordic countries and in the US, examined the risk of neurodevelopmental disorders (NDDs) following gestational exposure to APs. The Nordic study found that, in unadjusted analyses, exposure to APs during pregnancy was associated with increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in offspring; that the risk all but disappeared after adjusting for covariates; and that the risk appeared to be related to maternal major mental illness rather than to gestational exposure to APs. The US study also found that, in unadjusted analyses, gestational exposure to APs was associated with an increased risk of almost all of the study-specified NDDs in offspring; however, after adjusting for covariates, the risks were no longer meaningfully increased and, importantly, were no longer statistically significant for ADHD and ASD. Thus, these 2 studies suggest that gestational exposure to APs is a marker of NDD risk in offspring rather than a potential cause. Whereas a small but significantly increased risk was identified for aripiprazole in the US study, the signal was inconsistent across analyses, and confounding due to maternal mental illness was not ruled out. Previous studies have suggested that the use of APs during pregnancy is not associated with an increased risk of major congenital malformations and other adverse gestational outcomes. Considering the potential harm and suffering associated with major mental illness and the very low risks associated with AP use during pregnancy, initiation or continuation of APs appears to carry a favorable risk-benefit ratio in pregnant women who need these drugs; however, decision-making should be shared between patients, their caregivers, and the treating team.
{"title":"Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder, and Other Neurodevelopmental Outcomes Associated With Antipsychotic Drug Exposure During Pregnancy.","authors":"C. Andrade","doi":"10.4088/jcp.22f14529","DOIUrl":"https://doi.org/10.4088/jcp.22f14529","url":null,"abstract":"Between 0.3%-4.6% of women use antipsychotic (AP) drugs during pregnancy. Two large, retrospective, population-based cohort studies, conducted in Nordic countries and in the US, examined the risk of neurodevelopmental disorders (NDDs) following gestational exposure to APs. The Nordic study found that, in unadjusted analyses, exposure to APs during pregnancy was associated with increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in offspring; that the risk all but disappeared after adjusting for covariates; and that the risk appeared to be related to maternal major mental illness rather than to gestational exposure to APs. The US study also found that, in unadjusted analyses, gestational exposure to APs was associated with an increased risk of almost all of the study-specified NDDs in offspring; however, after adjusting for covariates, the risks were no longer meaningfully increased and, importantly, were no longer statistically significant for ADHD and ASD. Thus, these 2 studies suggest that gestational exposure to APs is a marker of NDD risk in offspring rather than a potential cause. Whereas a small but significantly increased risk was identified for aripiprazole in the US study, the signal was inconsistent across analyses, and confounding due to maternal mental illness was not ruled out. Previous studies have suggested that the use of APs during pregnancy is not associated with an increased risk of major congenital malformations and other adverse gestational outcomes. Considering the potential harm and suffering associated with major mental illness and the very low risks associated with AP use during pregnancy, initiation or continuation of APs appears to carry a favorable risk-benefit ratio in pregnant women who need these drugs; however, decision-making should be shared between patients, their caregivers, and the treating team.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75348704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Iosifescu, A. Jones, C. O'gorman, C. Streicher, Samantha Feliz, M. Fava, H. Tabuteau
Objective: Altered glutamatergic neurotransmission has been implicated in the pathogenesis of depression. This trial evaluated the efficacy and safety of AXS-05 (dextromethorphan-bupropion), an oral N-methyl-D-aspartate (NMDA) receptor antagonist and σ1 receptor agonist, in the treatment of major depressive disorder (MDD). Methods: This double-blind, phase 3 trial, was conducted between June 2019 and December 2019. Patients with a DSM-5 diagnosis of MDD were randomized in a 1:1 ratio to receive dextromethorphan-bupropion (45 mg-105 mg tablet) or placebo, orally (once daily for days 1-3, twice daily thereafter) for 6 weeks. The primary endpoint was the change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Other efficacy endpoints and variables included MADRS changes from baseline at week 1 and 2, clinical remission (MADRS score ≤ 10), clinical response (≥ 50% reduction in MADRS score from baseline), clinician- and patient-rated global assessments, Quick Inventory of Depressive Symptomatology-Self-Rated, Sheehan Disability Scale, and quality of life measures. Results: A total of 327 patients were randomized: 163 patients to dextromethorphan-bupropion and 164 patients to placebo. Mean baseline MADRS total scores were 33.6 and 33.2 in the dextromethorphan-bupropion and placebo groups, respectively. The least-squares mean change from baseline to week 6 in MADRS total score was -15.9 points in the dextromethorphan-bupropion group and -12.0 points in the placebo group (least-squares mean difference, -3.87; 95% confidence interval [CI], -1.39 to -6.36; P = .002). Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 (P = .007) and week 2 (P < .001). Remission was achieved by 39.5% of patients with dextromethorphan-bupropion versus 17.3% with placebo (treatment difference, 22.2; 95% CI, 11.7 to 32.7; P < .001), and clinical response by 54.0% versus 34.0%, respectively (treatment difference, 20.0%; 95% CI, 8.4%, 31.6%; P < .001), at week 6. Results for most secondary endpoints were significantly better with dextromethorphan-bupropion than with placebo at almost all time points (eg, CGI-S least-squares mean difference at week 6, -0.48; 95% CI, -0.48 to -0.79; P = .002). The most common adverse events in the dextromethorphan-bupropion group were dizziness, nausea, headache, somnolence, and dry mouth. Dextromethorphan-bupropion was not associated with psychotomimetic effects, weight gain, or increased sexual dysfunction. Conclusions: In this phase 3 trial in patients with MDD, treatment with dextromethorphan-bupropion (AXS-05) resulted in significant improvements in depressive symptoms compared to placebo starting 1 week after treatment initiation and was generally well tolerated. Trial Registration: ClinicalTrials.gov Identifier: NCT04019704.
{"title":"Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).","authors":"D. Iosifescu, A. Jones, C. O'gorman, C. Streicher, Samantha Feliz, M. Fava, H. Tabuteau","doi":"10.4088/jcp.21m14345","DOIUrl":"https://doi.org/10.4088/jcp.21m14345","url":null,"abstract":"Objective: Altered glutamatergic neurotransmission has been implicated in the pathogenesis of depression. This trial evaluated the efficacy and safety of AXS-05 (dextromethorphan-bupropion), an oral N-methyl-D-aspartate (NMDA) receptor antagonist and σ1 receptor agonist, in the treatment of major depressive disorder (MDD).\u0000Methods: This double-blind, phase 3 trial, was conducted between June 2019 and December 2019. Patients with a DSM-5 diagnosis of MDD were randomized in a 1:1 ratio to receive dextromethorphan-bupropion (45 mg-105 mg tablet) or placebo, orally (once daily for days 1-3, twice daily thereafter) for 6 weeks. The primary endpoint was the change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Other efficacy endpoints and variables included MADRS changes from baseline at week 1 and 2, clinical remission (MADRS score ≤ 10), clinical response (≥ 50% reduction in MADRS score from baseline), clinician- and patient-rated global assessments, Quick Inventory of Depressive Symptomatology-Self-Rated, Sheehan Disability Scale, and quality of life measures.\u0000Results: A total of 327 patients were randomized: 163 patients to dextromethorphan-bupropion and 164 patients to placebo. Mean baseline MADRS total scores were 33.6 and 33.2 in the dextromethorphan-bupropion and placebo groups, respectively. The least-squares mean change from baseline to week 6 in MADRS total score was -15.9 points in the dextromethorphan-bupropion group and -12.0 points in the placebo group (least-squares mean difference, -3.87; 95% confidence interval [CI], -1.39 to -6.36; P = .002). Dextromethorphan-bupropion was superior to placebo for MADRS improvement at all time points including week 1 (P = .007) and week 2 (P < .001). Remission was achieved by 39.5% of patients with dextromethorphan-bupropion versus 17.3% with placebo (treatment difference, 22.2; 95% CI, 11.7 to 32.7; P < .001), and clinical response by 54.0% versus 34.0%, respectively (treatment difference, 20.0%; 95% CI, 8.4%, 31.6%; P < .001), at week 6. Results for most secondary endpoints were significantly better with dextromethorphan-bupropion than with placebo at almost all time points (eg, CGI-S least-squares mean difference at week 6, -0.48; 95% CI, -0.48 to -0.79; P = .002). The most common adverse events in the dextromethorphan-bupropion group were dizziness, nausea, headache, somnolence, and dry mouth. Dextromethorphan-bupropion was not associated with psychotomimetic effects, weight gain, or increased sexual dysfunction.\u0000Conclusions: In this phase 3 trial in patients with MDD, treatment with dextromethorphan-bupropion (AXS-05) resulted in significant improvements in depressive symptoms compared to placebo starting 1 week after treatment initiation and was generally well tolerated.\u0000Trial Registration: ClinicalTrials.gov Identifier: NCT04019704.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86631451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Antidepressant drugs are effective against depression. They also improve subjective and functional outcomes such as disability, work functioning, social functioning, well-being, and health-related quality of life (HRQoL) in depressed patients. However, a recent large retrospective cohort study found that depressed subjects who received vs did not receive antidepressants did not differ in improvement in HRQoL, as measured using the 12-item Short Form (SF-12) Health Survey at the start and at the end of a 2-year period. The authors of the study therefore questioned the benefits of continuation of antidepressant drugs, suggesting a role for nonpharmacological interventions, instead. The study "went viral"; its findings were widely disseminated in the mass media and at medical and health care websites for physicians and for the lay public. The study, however, suffered from serious methodological shortcomings. These shortcomings are systematically explained so that readers understand how to critically read a research paper. This is important because uncritical acceptance of the findings of the study can negatively impact attitudes toward antidepressant medication among patients and health care professionals and may even result in decreased medication adherence in patients receiving antidepressant maintenance therapy.
{"title":"Antidepressant Drugs and Health-Related Quality of Life: A Reader's Guide on How to Examine a \"Viral\" Research Paper With a Critical Eye.","authors":"C. Andrade","doi":"10.4088/JCP.22f14527","DOIUrl":"https://doi.org/10.4088/JCP.22f14527","url":null,"abstract":"Antidepressant drugs are effective against depression. They also improve subjective and functional outcomes such as disability, work functioning, social functioning, well-being, and health-related quality of life (HRQoL) in depressed patients. However, a recent large retrospective cohort study found that depressed subjects who received vs did not receive antidepressants did not differ in improvement in HRQoL, as measured using the 12-item Short Form (SF-12) Health Survey at the start and at the end of a 2-year period. The authors of the study therefore questioned the benefits of continuation of antidepressant drugs, suggesting a role for nonpharmacological interventions, instead. The study \"went viral\"; its findings were widely disseminated in the mass media and at medical and health care websites for physicians and for the lay public. The study, however, suffered from serious methodological shortcomings. These shortcomings are systematically explained so that readers understand how to critically read a research paper. This is important because uncritical acceptance of the findings of the study can negatively impact attitudes toward antidepressant medication among patients and health care professionals and may even result in decreased medication adherence in patients receiving antidepressant maintenance therapy.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88575555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Scott, Mina Bakhit, Hannah Greenwood, M. Cardona, J. Clark, N. Krzyżaniak, R. Peiris, P. Glasziou
Objective: We conducted a systematic review and meta-analysis of randomized controlled trials comparing real-time telehealth (video, phone) with face-to-face therapy delivery to individuals with posttraumatic stress disorder (PTSD), by primary or allied health care practitioners. Data Sources: We searched MEDLINE, Embase, CINAHL, and Cochrane Central (inception to November 18, 2020); conducted a citation analysis on included studies (January 7, 2021) in Web of Science; and searched ClinicalTrials.gov and WHO ICTRP (March 25, 2021). No language or publication date restrictions were used. Study Selection: From 4,651 individual records screened, 13 trials (27 references) met the inclusion criteria. Data Extraction: Data on PTSD severity, depression severity, quality of life, therapeutic alliance, and treatment satisfaction outcomes were extracted. Results: There were no differences between telehealth and face-to-face for PTSD severity (at 6 months: standardized mean difference [SMD] = -0.11; 95% CI, -0.28 to 0.06), depression severity (at 6 months: SMD = -0.02; 95% CI, -0.26 to 0.22; P = .87), therapeutic alliance (at 3 months: SMD = 0.04; 95% CI, -0.51 to 0.59; P = .90), or treatment satisfaction (at 3 months: mean difference = 3.09; 95% CI, -7.76 to 13.94; P = .58). One trial reported similar changes in quality of life in telehealth and face-to-face. Conclusions: Telehealth appears to be a viable alternative for care provision to patients with PTSD. Trials evaluating therapy provision by telephone, and in populations other than veterans, are warranted.
{"title":"Real-Time Telehealth Versus Face-to-Face Management for Patients With PTSD in Primary Care: A Systematic Review and Meta-Analysis.","authors":"A. Scott, Mina Bakhit, Hannah Greenwood, M. Cardona, J. Clark, N. Krzyżaniak, R. Peiris, P. Glasziou","doi":"10.4088/JCP.21r14143","DOIUrl":"https://doi.org/10.4088/JCP.21r14143","url":null,"abstract":"Objective: We conducted a systematic review and meta-analysis of randomized controlled trials comparing real-time telehealth (video, phone) with face-to-face therapy delivery to individuals with posttraumatic stress disorder (PTSD), by primary or allied health care practitioners.\u0000Data Sources: We searched MEDLINE, Embase, CINAHL, and Cochrane Central (inception to November 18, 2020); conducted a citation analysis on included studies (January 7, 2021) in Web of Science; and searched ClinicalTrials.gov and WHO ICTRP (March 25, 2021). No language or publication date restrictions were used.\u0000Study Selection: From 4,651 individual records screened, 13 trials (27 references) met the inclusion criteria.\u0000Data Extraction: Data on PTSD severity, depression severity, quality of life, therapeutic alliance, and treatment satisfaction outcomes were extracted.\u0000Results: There were no differences between telehealth and face-to-face for PTSD severity (at 6 months: standardized mean difference [SMD] = -0.11; 95% CI, -0.28 to 0.06), depression severity (at 6 months: SMD = -0.02; 95% CI, -0.26 to 0.22; P = .87), therapeutic alliance (at 3 months: SMD = 0.04; 95% CI, -0.51 to 0.59; P = .90), or treatment satisfaction (at 3 months: mean difference = 3.09; 95% CI, -7.76 to 13.94; P = .58). One trial reported similar changes in quality of life in telehealth and face-to-face.\u0000Conclusions: Telehealth appears to be a viable alternative for care provision to patients with PTSD. Trials evaluating therapy provision by telephone, and in populations other than veterans, are warranted.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81628199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I will address the question posed in the title at the end of this commentary. The meta-analysis by Scott and colleagues1 in this issue found that video-based telehealth treatment of posttraumatic stress disorder (PTSD) in primary care was as effective in reducing symptoms as face-to-face treatment. Moreover, the therapeutic alliance was as strong, and patient satisfaction as high, in telehealth as in-person treatment. These findings for PTSD are consistent with the results of other reviews and meta-analyses that found equivalent efficacy and patient satisfaction between telehealth and face-to-face treatment for insomnia,2 substance use disorders,3 obsessive-compulsive disorder,4 depression,5 and schizophrenia spectrum disorders6 and in samples of patients with a mixture of psychiatric diagnoses.5 Telehealth interventions as adjuncts to routine care have also been found to be effective in addressing other clinically important behaviors such as enhancing medication compliance.7 In outpatient settings, appointment attendance is greater with telehealth versus in-person visits.8–10 To be sure, telehealth interventions have not been limited to patients with psychiatric disorders and have been found to be effective in other areas of medicine.11 The literature on telehealth interventions, including both telephone and televideo, goes back decades. However, the recent COVID-19 pandemic, which spurred recommendations for social distancing and other precautionary measures, resulted in a rapid transition from in-person to telehealth visits, especially in behavioral health.12 The change in how visits are conducted has been greatest in ambulatory care, though it also has occurred in emergency rooms13 and inpatient units.14,15 The widespread transition to telemedicine was economically feasible because reimbursement for services was not reduced. In part, equivalent compensation for telehealth treatment was compelled by government regulation. The COVID-19 pandemic will not pervade society forever. Thus, the ongoing role of telehealth treatment in the delivery of treatment, particularly ambulatory behavioral health treatment, is uncertain. While some states have mandated an expansion of telehealth services and required private payers to continue to reimburse telehealth services at the same level as in-person treatment, other states have already rescinded, or allowed to expire, emergency orders that required equivalent telehealth reimbursements. What will the future hold? Government regulatory agencies, at both the federal and state levels, will largely determine how widespread telehealth behavioral services will remain. To be sure, telehealth behavioral services will retain some presence because of the shortage of behavioral health providers in many areas. An as yet potential area of growth for telehealth treatment is the “expertise niche” in which clinical programs with renowned expertise in treating specific disorders expand their geographic reach. During the pan
我将在这篇评论的最后回答标题中提出的问题。斯科特和他的同事在本期的荟萃分析中发现，在初级保健中对创伤后应激障碍(PTSD)进行基于视频的远程医疗治疗，在减轻症状方面与面对面治疗一样有效。此外，远程医疗的治疗联盟与面对面治疗一样强大，患者满意度也一样高。这些关于创伤后应激障碍的发现与其他综述和荟萃分析的结果是一致的，这些综述和荟萃分析发现，对于失眠、物质使用障碍、强迫症、抑郁症、精神分裂症谱系障碍以及患有多种精神病诊断的患者样本，远程医疗和面对面治疗的疗效和患者满意度是相同的作为常规护理的辅助手段的远程保健干预也被发现在处理其他临床重要行为(如加强药物依从性)方面是有效的在门诊设置中，远程医疗的预约出勤率高于亲自就诊。8-10可以肯定的是，远程保健干预措施并不局限于精神病患者，而且已发现在其他医学领域也很有效关于远程医疗干预的文献，包括电话和电视，可以追溯到几十年前。然而，最近的COVID-19大流行引发了有关保持社交距离和其他预防措施的建议，导致了从面对面就诊到远程就诊的迅速转变，特别是在行为健康方面虽然急诊室和住院部也发生了这种变化，但门诊就诊方式的变化最大。14,15广泛过渡到远程医疗在经济上是可行的，因为服务的报销没有减少。在某种程度上，远程医疗治疗的同等补偿是由政府法规强制规定的。COVID-19大流行不会永远笼罩整个社会。因此，远程保健治疗在提供治疗，特别是门诊行为健康治疗中的持续作用是不确定的。虽然一些州已授权扩大远程保健服务，并要求私人付款人继续按照与面对面治疗相同的水平偿还远程保健服务，但其他州已经取消或允许到期要求同等远程保健偿还的紧急命令。未来会怎样?联邦和州一级的政府管理机构将在很大程度上决定远程保健行为服务的普及程度。可以肯定的是，由于许多地区缺乏行为保健提供者，远程保健行为服务将保留一些存在。远程医疗治疗的一个潜在增长领域是“专业知识利基”，即在治疗特定疾病方面具有知名专业知识的临床项目扩大其地理覆盖范围。在大流行期间，具有特殊专业知识的方案在此之前没有远程医疗经验，但经过调整，它们适应了远程医疗治疗的提供，并可能寻求扩大服务，因为物理空间要求带来的限制将会减少。无论出于何种原因，远程医疗在未来都将有所保留。尚待确定的是，远程保健是否将成为门诊行为保健的规范(或接近规范)，让患者可以选择亲自或通过远程保健看临床医生，或者远程保健是否将重新成为提供护理的一小部分。政府监管机构将如何决定是继续扩大远程医疗服务，还是回到大流行前的状态?毫无疑问，游说者，无论是支持还是反对，都会试图施加他们的影响。会有什么科学依据的论点?在covid之前已经进行了大量研究。事实上，斯科特及其同事荟萃分析中的所有治疗研究都是在COVID-19大流行之前进行的。大流行期间出现了科学的爆炸式发展。在2021年11月30日进行的PubMed搜索中，远程医疗和精神病学这两个术语在过去30年里被引用了3757次，其中超过15% (n = 584)已经在2021年发表。文献几乎是一致的——几乎所有比较远程医疗和现场治疗的研究都发现了同样的疗效、安全性和患者满意度。5,16,17同等功效并不令人惊讶。考虑以下基于治疗反应对患者进行分型的概念方法。在评估对两种有效治疗的反应时，关键问题是，有多少患者和哪些患者会表现出不同的治疗反应?也就是说，有多少病人会对一种治疗有反应，而对另一种治疗没有反应?治疗反应有4种亚型。 第一组由对非特异性a有反应的患者组成:布朗医学院精神病学和人类行为学系，罗德岛州普罗维登斯罗得岛医院精神病学学系*通讯作者:Mark Zimmerman, MD, 146 West River St，普罗维登斯，RI 02904 (mzimmerman@lifespan.org)。中华临床精神病学杂志;2009;31 (4):361 - 361
{"title":"Should Blind Psychiatrists Be Paid Less?","authors":"M. Zimmerman","doi":"10.4088/jcp.21com14354","DOIUrl":"https://doi.org/10.4088/jcp.21com14354","url":null,"abstract":"I will address the question posed in the title at the end of this commentary. The meta-analysis by Scott and colleagues1 in this issue found that video-based telehealth treatment of posttraumatic stress disorder (PTSD) in primary care was as effective in reducing symptoms as face-to-face treatment. Moreover, the therapeutic alliance was as strong, and patient satisfaction as high, in telehealth as in-person treatment. These findings for PTSD are consistent with the results of other reviews and meta-analyses that found equivalent efficacy and patient satisfaction between telehealth and face-to-face treatment for insomnia,2 substance use disorders,3 obsessive-compulsive disorder,4 depression,5 and schizophrenia spectrum disorders6 and in samples of patients with a mixture of psychiatric diagnoses.5 Telehealth interventions as adjuncts to routine care have also been found to be effective in addressing other clinically important behaviors such as enhancing medication compliance.7 In outpatient settings, appointment attendance is greater with telehealth versus in-person visits.8–10 To be sure, telehealth interventions have not been limited to patients with psychiatric disorders and have been found to be effective in other areas of medicine.11 The literature on telehealth interventions, including both telephone and televideo, goes back decades. However, the recent COVID-19 pandemic, which spurred recommendations for social distancing and other precautionary measures, resulted in a rapid transition from in-person to telehealth visits, especially in behavioral health.12 The change in how visits are conducted has been greatest in ambulatory care, though it also has occurred in emergency rooms13 and inpatient units.14,15 The widespread transition to telemedicine was economically feasible because reimbursement for services was not reduced. In part, equivalent compensation for telehealth treatment was compelled by government regulation. The COVID-19 pandemic will not pervade society forever. Thus, the ongoing role of telehealth treatment in the delivery of treatment, particularly ambulatory behavioral health treatment, is uncertain. While some states have mandated an expansion of telehealth services and required private payers to continue to reimburse telehealth services at the same level as in-person treatment, other states have already rescinded, or allowed to expire, emergency orders that required equivalent telehealth reimbursements. What will the future hold? Government regulatory agencies, at both the federal and state levels, will largely determine how widespread telehealth behavioral services will remain. To be sure, telehealth behavioral services will retain some presence because of the shortage of behavioral health providers in many areas. An as yet potential area of growth for telehealth treatment is the “expertise niche” in which clinical programs with renowned expertise in treating specific disorders expand their geographic reach. During the pan","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90879753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: This study aimed to survey clinicians' attitudes in Singapore and Hong Kong toward clozapine and elucidate the barriers to its prescription in patients with treatment-resistant schizophrenia. Methods: All clinicians in psychiatry in both regions were invited through email to participate in an anonymous online survey. The survey collected information on the participants' characteristics, their experience with clozapine initiation, perceived usefulness of clozapine, barriers to clozapine initiation, and factors that might improve clozapine use. Data collection took place between December 2018 and March 2019 in Singapore and September 2019 and February 2020 in Hong Kong. Results: A total of 261 clinicians (156 in Singapore, 105 in Hong Kong) responded to the survey. The majority of participants believed that clozapine was an effective and satisfactory treatment for schizophrenia. Clinicians were most concerned about the need for frequent blood monitoring (84.5% in Singapore; 87.5% in Hong Kong), clozapine's tolerability (51.9% in Singapore; 61.6% in Hong Kong), and medical complications (54.8% in Singapore; 49.1% in Hong Kong). Compared to Hong Kong, more clinicians in Singapore endorsed an underutilization of clozapine (67.9% in Singapore; 51.4% in Hong Kong) and a greater need for outpatient resources in terms of clinic and administrative support (74.4% in Singapore; 59.0% in Hong Kong) to improve clozapine prescription. Conclusions: The underutilization of clozapine in treatment-resistant schizophrenia remains a concern in both regions. An integrated clozapine service that addresses the system barriers and clinicians' confidence in prescribing clozapine and managing its adverse effects would greatly improve the utilization of clozapine.
{"title":"Utility and Barriers to Clozapine Use: A Joint Study of Clinicians' Attitudes From Singapore and Hong Kong.","authors":"Shushan Zheng, Jimmy Lee, S. Chan","doi":"10.4088/jcp.21m14231","DOIUrl":"https://doi.org/10.4088/jcp.21m14231","url":null,"abstract":"Objective: This study aimed to survey clinicians' attitudes in Singapore and Hong Kong toward clozapine and elucidate the barriers to its prescription in patients with treatment-resistant schizophrenia.\u0000Methods: All clinicians in psychiatry in both regions were invited through email to participate in an anonymous online survey. The survey collected information on the participants' characteristics, their experience with clozapine initiation, perceived usefulness of clozapine, barriers to clozapine initiation, and factors that might improve clozapine use. Data collection took place between December 2018 and March 2019 in Singapore and September 2019 and February 2020 in Hong Kong.\u0000Results: A total of 261 clinicians (156 in Singapore, 105 in Hong Kong) responded to the survey. The majority of participants believed that clozapine was an effective and satisfactory treatment for schizophrenia. Clinicians were most concerned about the need for frequent blood monitoring (84.5% in Singapore; 87.5% in Hong Kong), clozapine's tolerability (51.9% in Singapore; 61.6% in Hong Kong), and medical complications (54.8% in Singapore; 49.1% in Hong Kong). Compared to Hong Kong, more clinicians in Singapore endorsed an underutilization of clozapine (67.9% in Singapore; 51.4% in Hong Kong) and a greater need for outpatient resources in terms of clinic and administrative support (74.4% in Singapore; 59.0% in Hong Kong) to improve clozapine prescription.\u0000Conclusions: The underutilization of clozapine in treatment-resistant schizophrenia remains a concern in both regions. An integrated clozapine service that addresses the system barriers and clinicians' confidence in prescribing clozapine and managing its adverse effects would greatly improve the utilization of clozapine.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84290163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Trivedi, Karabi Nandy, T. Mayes, Tianyi Wang, Kathryn Forbes, Jacqueline R. Anderson, A. Fuller, Jennifer L. Hughes
Objective: To determine the state of mental health problems among a general youth population and assess whether the Youth Aware of Mental Health (YAM) intervention can improve symptoms of depression and anxiety. Methods: We implemented YAM with a cluster quasi-experimental study design from August 2017 through June 2019 in 29 middle schools and high schools in North Texas. Students completed the Quick Inventory of Depressive Symptomatology, Adolescent version; the Generalized Anxiety Disorder Screener; and additional substance use questionnaires before YAM delivery and 3-6 months after implementation. Multilevel models, with students nested within schools, were used to model difference scores of depression and anxiety, controlling for various student-level and school-level characteristics. Missing data were imputed during analysis. Sensitivity analyses were performed on non-imputed data. Results: Among 3,302 adolescents at pre-test, 27% had moderate-to-severe depression, 22% had moderate-to-severe anxiety, and 4% expressed suicidal ideation. We found that on average, compared to those who had no depression at pre-test, depression decreased at post-test by (a) 4.62 units (P < .05) for those who had severe to very severe depression at pre-test, (b) 2.92 units (P < .0001) for those who had moderate depression at pre-test, and (c) 1.5 units (P < .001) for those who had mild depression at pre-test, controlling for all other factors in the model. Similar significant decreases were observed in anxiety, controlling for student-level characteristics. Conclusions: These findings demonstrate the effectiveness of YAM in reducing symptoms of depression and anxiety among adolescents in North Texas.
{"title":"Youth Aware of Mental Health (YAM) Program With Texas Adolescents: Depression, Anxiety, and Substance Use Outcomes.","authors":"M. Trivedi, Karabi Nandy, T. Mayes, Tianyi Wang, Kathryn Forbes, Jacqueline R. Anderson, A. Fuller, Jennifer L. Hughes","doi":"10.4088/jcp.21m14221","DOIUrl":"https://doi.org/10.4088/jcp.21m14221","url":null,"abstract":"Objective: To determine the state of mental health problems among a general youth population and assess whether the Youth Aware of Mental Health (YAM) intervention can improve symptoms of depression and anxiety.\u0000Methods: We implemented YAM with a cluster quasi-experimental study design from August 2017 through June 2019 in 29 middle schools and high schools in North Texas. Students completed the Quick Inventory of Depressive Symptomatology, Adolescent version; the Generalized Anxiety Disorder Screener; and additional substance use questionnaires before YAM delivery and 3-6 months after implementation. Multilevel models, with students nested within schools, were used to model difference scores of depression and anxiety, controlling for various student-level and school-level characteristics. Missing data were imputed during analysis. Sensitivity analyses were performed on non-imputed data.\u0000Results: Among 3,302 adolescents at pre-test, 27% had moderate-to-severe depression, 22% had moderate-to-severe anxiety, and 4% expressed suicidal ideation. We found that on average, compared to those who had no depression at pre-test, depression decreased at post-test by (a) 4.62 units (P < .05) for those who had severe to very severe depression at pre-test, (b) 2.92 units (P < .0001) for those who had moderate depression at pre-test, and (c) 1.5 units (P < .001) for those who had mild depression at pre-test, controlling for all other factors in the model. Similar significant decreases were observed in anxiety, controlling for student-level characteristics.\u0000Conclusions: These findings demonstrate the effectiveness of YAM in reducing symptoms of depression and anxiety among adolescents in North Texas.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84039416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diana Khoubaeva, Mikaela K. Dimick, J. Roane, Vanessa H. Timmins, Rachel H. B. Mitchell, B. Goldstein
Objective: There is growing recognition of the importance of comorbid eating disorders (ED) among individuals with bipolar disorder (BD). However, most studies on this topic have focused on adult samples, and little is known regarding comorbid ED among youth with BD. Methods: The sample included 197 youth with DSM-IV BD (BD-I, BD-II, or BD-NOS [not otherwise specified]), aged 13-20 years and recruited from a subspecialized clinic within a tertiary academic health sciences center from 2009 to 2017. Univariate analyses examined demographic and clinical variables among participants with versus without lifetime DSM-IV ED. Variables significant at P < .10 were entered into a backward stepwise regression. Results: Fifty-six participants (28.4%) had lifetime DSM-IV ED (3.6% anorexia nervosa, 8.1% bulimia nervosa, 16.8% ED not otherwise specified). Significant correlates of lifetime ED were female sex (P < .001), BD-II subtype (P = .03), suicidal ideation (P = .006), suicide attempts (P = .004), non-suicidal self-injury (P < .001), sexual abuse (P = .02), cigarette smoking (P = .001), anxiety disorders (P = .004), posttraumatic stress disorder (P = .004), substance use disorders (P = .006), history of individual therapy (P = .01), and family history of anxiety (P = .01). Significant correlates of no lifetime ED were BD-I subtype (P < .001) and lifetime lithium use (P = .01). The ED group had significantly more severe lifetime depression (P < .001) and significantly more self-reported affective lability (P < .001) and borderline personality traits (P < .001). In multivariate analysis, the most robust predictors of lifetime ED were female sex (odds ratio [OR] = 4.61, P = .004), BD-I subtype (OR = 0.21, P = .03), cigarette smoking (OR = 2.78, P = .02), individual therapy (OR = 3.92, P = .03), family history of anxiety (OR = 2.86, P = .02), and borderline personality traits (OR = 1.01, P = .009). Conclusions: ED are common among youth with BD and associated with adverse clinical characteristics, many of which converge with prior adult literature. Future studies evaluating specific ED subtypes are warranted, as are treatment studies targeting comorbid ED in youth with BD.
{"title":"Comorbid Eating Disorders in a Sample of Youth With Bipolar Disorder: Elevated Burden of Dimensional and Categorical Psychopathology.","authors":"Diana Khoubaeva, Mikaela K. Dimick, J. Roane, Vanessa H. Timmins, Rachel H. B. Mitchell, B. Goldstein","doi":"10.4088/jcp.21r14201","DOIUrl":"https://doi.org/10.4088/jcp.21r14201","url":null,"abstract":"Objective: There is growing recognition of the importance of comorbid eating disorders (ED) among individuals with bipolar disorder (BD). However, most studies on this topic have focused on adult samples, and little is known regarding comorbid ED among youth with BD.\u0000Methods: The sample included 197 youth with DSM-IV BD (BD-I, BD-II, or BD-NOS [not otherwise specified]), aged 13-20 years and recruited from a subspecialized clinic within a tertiary academic health sciences center from 2009 to 2017. Univariate analyses examined demographic and clinical variables among participants with versus without lifetime DSM-IV ED. Variables significant at P < .10 were entered into a backward stepwise regression.\u0000Results: Fifty-six participants (28.4%) had lifetime DSM-IV ED (3.6% anorexia nervosa, 8.1% bulimia nervosa, 16.8% ED not otherwise specified). Significant correlates of lifetime ED were female sex (P < .001), BD-II subtype (P = .03), suicidal ideation (P = .006), suicide attempts (P = .004), non-suicidal self-injury (P < .001), sexual abuse (P = .02), cigarette smoking (P = .001), anxiety disorders (P = .004), posttraumatic stress disorder (P = .004), substance use disorders (P = .006), history of individual therapy (P = .01), and family history of anxiety (P = .01). Significant correlates of no lifetime ED were BD-I subtype (P < .001) and lifetime lithium use (P = .01). The ED group had significantly more severe lifetime depression (P < .001) and significantly more self-reported affective lability (P < .001) and borderline personality traits (P < .001). In multivariate analysis, the most robust predictors of lifetime ED were female sex (odds ratio [OR] = 4.61, P = .004), BD-I subtype (OR = 0.21, P = .03), cigarette smoking (OR = 2.78, P = .02), individual therapy (OR = 3.92, P = .03), family history of anxiety (OR = 2.86, P = .02), and borderline personality traits (OR = 1.01, P = .009).\u0000Conclusions: ED are common among youth with BD and associated with adverse clinical characteristics, many of which converge with prior adult literature. Future studies evaluating specific ED subtypes are warranted, as are treatment studies targeting comorbid ED in youth with BD.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85499550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Weiden, A. Breier, Sarah Kavanagh, Andrew C. Miller, S. Brannan, S. Paul
Objective: To evaluate Positive and Negative Syndrome Scale (PANSS) categorical response rates, time course of response, and symptom subdomains of response with the combination oral agent KarXT (xanomeline-trospium) in the treatment of schizophrenia. Methods: Post hoc analysis was conducted for EMERGENT-1 (NCT03697252), a 5-week, inpatient, placebo-controlled, phase 2 study of acute psychosis in patients who met DSM-5 criteria for schizophrenia. The EMERGENT-1 study was conducted between September 2018 and August 2019. Categorical thresholds of response used were PANSS total score reductions of ≥ 20%, ≥ 30%, ≥ 40%, and ≥ 50% between baseline and study end. Number needed to treat (NNT) for each categorical threshold was calculated. The proportion of KarXT- and placebo-treated patients achieving each response threshold at weeks 2, 4, and 5 was assessed. Marder 5-factor analysis of PANSS assessed response with KarXT across symptom domains. Results: A total of 83 patients in the KarXT group and 87 patients in the placebo group were included in the modified intent-to-treat analysis. Response rates with KarXT ranged from 59.0% for a ≥ 20% threshold to 15.7% for a ≥ 50% threshold. All response rates with KarXT were significantly higher than in the placebo arm (P < .05), with NNTs ranging from 3 (≥ 20% improvement) to 11 (≥ 50% improvement). KarXT was associated with a significantly higher response rate relative to placebo as early as 2 weeks for ≥ 20% (P = .0001) and ≥ 30% (P = .0022) thresholds and at 4 weeks for the ≥ 40% (P = .0049) and ≥ 50% (P = .0041) thresholds. Each of the Marder 5 factors showed significant differences favoring KarXT over placebo (P < .05) by 2 weeks and continuing through week 5 (endpoint Cohen d effect sizes, 0.48-0.66). Conclusions: KarXT provided clinically meaningful responder rates on PANSS total score compared with placebo at each response threshold, providing further support of the successful primary and secondary endpoints. Response was demonstrated as early as 2 weeks relative to placebo. KarXT demonstrated improvements vs placebo in all 5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression). Trial Registration: ClinicalTrials.gov identifier: NCT03697252.
{"title":"Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study.","authors":"P. Weiden, A. Breier, Sarah Kavanagh, Andrew C. Miller, S. Brannan, S. Paul","doi":"10.4088/jcp.21m14316","DOIUrl":"https://doi.org/10.4088/jcp.21m14316","url":null,"abstract":"Objective: To evaluate Positive and Negative Syndrome Scale (PANSS) categorical response rates, time course of response, and symptom subdomains of response with the combination oral agent KarXT (xanomeline-trospium) in the treatment of schizophrenia.\u0000Methods: Post hoc analysis was conducted for EMERGENT-1 (NCT03697252), a 5-week, inpatient, placebo-controlled, phase 2 study of acute psychosis in patients who met DSM-5 criteria for schizophrenia. The EMERGENT-1 study was conducted between September 2018 and August 2019. Categorical thresholds of response used were PANSS total score reductions of ≥ 20%, ≥ 30%, ≥ 40%, and ≥ 50% between baseline and study end. Number needed to treat (NNT) for each categorical threshold was calculated. The proportion of KarXT- and placebo-treated patients achieving each response threshold at weeks 2, 4, and 5 was assessed. Marder 5-factor analysis of PANSS assessed response with KarXT across symptom domains.\u0000Results: A total of 83 patients in the KarXT group and 87 patients in the placebo group were included in the modified intent-to-treat analysis. Response rates with KarXT ranged from 59.0% for a ≥ 20% threshold to 15.7% for a ≥ 50% threshold. All response rates with KarXT were significantly higher than in the placebo arm (P < .05), with NNTs ranging from 3 (≥ 20% improvement) to 11 (≥ 50% improvement). KarXT was associated with a significantly higher response rate relative to placebo as early as 2 weeks for ≥ 20% (P = .0001) and ≥ 30% (P = .0022) thresholds and at 4 weeks for the ≥ 40% (P = .0049) and ≥ 50% (P = .0041) thresholds. Each of the Marder 5 factors showed significant differences favoring KarXT over placebo (P < .05) by 2 weeks and continuing through week 5 (endpoint Cohen d effect sizes, 0.48-0.66).\u0000Conclusions: KarXT provided clinically meaningful responder rates on PANSS total score compared with placebo at each response threshold, providing further support of the successful primary and secondary endpoints. Response was demonstrated as early as 2 weeks relative to placebo. KarXT demonstrated improvements vs placebo in all 5 factors (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility, and anxiety/depression).\u0000Trial Registration: ClinicalTrials.gov identifier: NCT03697252.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80685650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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