Pub Date : 2023-08-09DOI: 10.4088/jcp.muladx3048sho
Ayana Jordan
Despite their legality, alcohol and tobacco both have a well-documented potential for misuse and elevate users' likelihood for disease. Dependence on alcohol also contributes to opioid overdoses, which claim 130 lives every day. Although awareness of the opioid epidemic is rising broadly among health care professionals, a majority of Americans still do not receive adequate, FDA-approved medications for their addiction. Effective medications are available for alcohol use disorder and medications for opioid use disorder have validated benefits that justify their use. In recent years, psychedelic compounds have attracted interest among scientists for their potential to alter mood and cognition in beneficial manners. Already, some evidence supports the use of psilocybin in alleviating symptoms of depression and anxiety; psychedelic compounds also have potential as alcohol use disorder treatments and may help reduce symptoms tied to opioid withdrawal. Because substance use disorders can culminate in death, a comprehensive, integrated, public health approach to the treatment of people with substance use disorders is essential.
{"title":"Emerging Perspectives in Addiction Psychiatry.","authors":"Ayana Jordan","doi":"10.4088/jcp.muladx3048sho","DOIUrl":"https://doi.org/10.4088/jcp.muladx3048sho","url":null,"abstract":"Despite their legality, alcohol and tobacco both have a well-documented potential for misuse and elevate users' likelihood for disease. Dependence on alcohol also contributes to opioid overdoses, which claim 130 lives every day. Although awareness of the opioid epidemic is rising broadly among health care professionals, a majority of Americans still do not receive adequate, FDA-approved medications for their addiction. Effective medications are available for alcohol use disorder and medications for opioid use disorder have validated benefits that justify their use. In recent years, psychedelic compounds have attracted interest among scientists for their potential to alter mood and cognition in beneficial manners. Already, some evidence supports the use of psilocybin in alleviating symptoms of depression and anxiety; psychedelic compounds also have potential as alcohol use disorder treatments and may help reduce symptoms tied to opioid withdrawal. Because substance use disorders can culminate in death, a comprehensive, integrated, public health approach to the treatment of people with substance use disorders is essential.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81661513","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}
Pub Date : 2023-08-09DOI: 10.4088/jcp.muladhd3048sho
J. Newcorn
Scan Now This CME Institute Showcase section of The Journal of Clinical Psychiatry presents the highlights of “Emerging Therapies for the Treatment of ADHD,” Session 1 from the conference series “Emerging Perspectives in Psychiatry,” which was held on June 24, 2023. This report was prepared and independently developed by the CME Institute of Physicians Postgraduate Press, Inc. Cite and Share this article at Psychiatrist.com Emerging Therapies for Attention-Deficit/Hyperactivity Disorder
{"title":"Emerging Therapies for Attention-Deficit/Hyperactivity Disorder","authors":"J. Newcorn","doi":"10.4088/jcp.muladhd3048sho","DOIUrl":"https://doi.org/10.4088/jcp.muladhd3048sho","url":null,"abstract":"Scan Now This CME Institute Showcase section of The Journal of Clinical Psychiatry presents the highlights of “Emerging Therapies for the Treatment of ADHD,” Session 1 from the conference series “Emerging Perspectives in Psychiatry,” which was held on June 24, 2023. This report was prepared and independently developed by the CME Institute of Physicians Postgraduate Press, Inc. Cite and Share this article at Psychiatrist.com Emerging Therapies for Attention-Deficit/Hyperactivity Disorder","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82701653","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}
{"title":"Charles Bowden, MD, 1938-2022.","authors":"T. Suppes, G. Sachs","doi":"10.4088/jcp.22f14635","DOIUrl":"https://doi.org/10.4088/jcp.22f14635","url":null,"abstract":"","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74087260","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}
{"title":"In Memoriam: Jan Fawcett, MD, 1934-2022.","authors":"A. Rush, S. Hollon","doi":"10.4088/JCP.22f14557","DOIUrl":"https://doi.org/10.4088/JCP.22f14557","url":null,"abstract":"","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82233461","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. Pompili, D. Erbuto, M. Innamorati, M. Luciano, G. Sampogna, G. Abbate-Daga, S. Barlati, C. Carmassi, G. Castellini, P. De Fazio, G. Di Lorenzo, M. Di Nicola, S. Ferrari, C. Gramaglia, M. Nanni, M. Pasquini, F. Pinna, N. Poloni, G. Serafini, M. Signorelli, A. Ventriglio, U. Volpe, A. Fiorillo
Objective: Mental pain and exposure to maltreatment are significant risk factors for suicidal behavior. This study aimed to investigate whether mental pain could be associated with a recent suicide attempt and whether it could mediate the relationship between childhood traumatic experiences and suicide risk in psychiatric patients. Methods: A multicenter observational study was organized as a joint project with representatives of numerous mixed Italian academic and clinical settings. Between December 2017 and March 2020, batteries of tests were administered to patients, assessing suicidal ideation and behavior, mental pain (usual and worst mental pain in the past 15 days), depression, and childhood maltreatment. Results: A total of 2,137 psychiatric patients (1,313 women and 824 men) were included in the final sample, and 315 reported having attempted suicide in the last 3 months. Suicide attempters (compared to nonattempters) had higher odds of reporting worse mental pain (odds ratios [ORs] between 1.02 and 1.17; P < .001) and suicidal intent with/without a specific plan (ORs between 11.57 and 11.77; P < .001). They also had higher odds of having a personality disorder (borderline personality disorder: ORs between 2.65 and 3.01; P < .001; other personality disorders: ORs between 1.96 and 2.28; P < .01) and major depression (ORs between 1.62 and 1.70; P < .05). Childhood trauma was associated with suicide risk directly (standardized effects between 0.06 and 0.07; P < .01) and indirectly through mental pain (usual mental pain: standardized indirect effect = 0.11, P < .001; worst mental pain in the past 15 days: standardized indirect effect = 0.12, P < .001). Conclusions: Mental pain constitutes a crucial framework for assessing the individual need for psychiatric help. Assessing mental pain allows identification of the main ingredient of suicide risk and puts the clinician in a strategic position to unlock some motives behind the wish to die. Further research is needed to learn if childhood adversities may interact with adult mental pain and thus foster suicide risk.
{"title":"The Relationship Between Mental Pain, Suicide Risk, and Childhood Traumatic Experiences: Results From a Multicenter Study.","authors":"M. Pompili, D. Erbuto, M. Innamorati, M. Luciano, G. Sampogna, G. Abbate-Daga, S. Barlati, C. Carmassi, G. Castellini, P. De Fazio, G. Di Lorenzo, M. Di Nicola, S. Ferrari, C. Gramaglia, M. Nanni, M. Pasquini, F. Pinna, N. Poloni, G. Serafini, M. Signorelli, A. Ventriglio, U. Volpe, A. Fiorillo","doi":"10.4088/jcp.21m14176","DOIUrl":"https://doi.org/10.4088/jcp.21m14176","url":null,"abstract":"Objective: Mental pain and exposure to maltreatment are significant risk factors for suicidal behavior. This study aimed to investigate whether mental pain could be associated with a recent suicide attempt and whether it could mediate the relationship between childhood traumatic experiences and suicide risk in psychiatric patients.\u0000Methods: A multicenter observational study was organized as a joint project with representatives of numerous mixed Italian academic and clinical settings. Between December 2017 and March 2020, batteries of tests were administered to patients, assessing suicidal ideation and behavior, mental pain (usual and worst mental pain in the past 15 days), depression, and childhood maltreatment.\u0000Results: A total of 2,137 psychiatric patients (1,313 women and 824 men) were included in the final sample, and 315 reported having attempted suicide in the last 3 months. Suicide attempters (compared to nonattempters) had higher odds of reporting worse mental pain (odds ratios [ORs] between 1.02 and 1.17; P < .001) and suicidal intent with/without a specific plan (ORs between 11.57 and 11.77; P < .001). They also had higher odds of having a personality disorder (borderline personality disorder: ORs between 2.65 and 3.01; P < .001; other personality disorders: ORs between 1.96 and 2.28; P < .01) and major depression (ORs between 1.62 and 1.70; P < .05). Childhood trauma was associated with suicide risk directly (standardized effects between 0.06 and 0.07; P < .01) and indirectly through mental pain (usual mental pain: standardized indirect effect = 0.11, P < .001; worst mental pain in the past 15 days: standardized indirect effect = 0.12, P < .001).\u0000Conclusions: Mental pain constitutes a crucial framework for assessing the individual need for psychiatric help. Assessing mental pain allows identification of the main ingredient of suicide risk and puts the clinician in a strategic position to unlock some motives behind the wish to die. Further research is needed to learn if childhood adversities may interact with adult mental pain and thus foster suicide risk.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88934942","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: To examine the relationship between maternal postnatal depression and completion of infant vaccinations. Methods: We conducted a cohort study using data from The Health Improvement Network (THIN), a large UK primary care electronic health record database. We identified 196,329 mother-infant pairs in which the infant was born between 2006 and 2015. Postnatal depression was identified through antidepressant prescriptions or diagnoses or symptoms of depression in first year after childbirth. Primary outcome was completion of three 5-in-1 vaccination doses in infants before 1 year of age; this vaccine protects against diphtheria, tetanus, whooping cough, polio, and Haemophilus influenzae type b. We used Poisson regression models to compare likelihood of infant 5-in-1 vaccine uptake among children of women with a record of postnatal depression to likelihood among those without. Results: Of the 196,329 women, 20,802 (10.6%) had a record of postnatal depression and/or antidepressant prescription. There was no difference in infants' 5-in-1 vaccination completion between those of mothers with a record and those of mothers' without (adjusted incidence rate ratio [IRR] = 1.01; 95% CI, 0.99-1.02). Those from more socially deprived areas were less likely to complete infant vaccinations compared to those from the least deprived areas (IRR = 0.92; 95% CI, 0.90-0.93). Likelihood of completing infant vaccination decreased over time, comparing 2014-2015 to 2006-2007 (IRR = 0.90; 95% CI, 0.89-0.92). Conclusions: Among mothers who engage with primary care, maternal postnatal depression is not associated with lower rates of infant vaccination, though more research is needed to conclude if either more severe depression or unrecognized depression is associated with lower completion rates.
{"title":"Maternal Postnatal Depression and Completion of Infant Immunizations: A UK Cohort Study of 196,329 Mother-Infant Pairs, 2006-2015.","authors":"H. C. Smith, S. Saxena, I. Petersen","doi":"10.4088/jcp.20m13575","DOIUrl":"https://doi.org/10.4088/jcp.20m13575","url":null,"abstract":"Objective: To examine the relationship between maternal postnatal depression and completion of infant vaccinations.\u0000Methods: We conducted a cohort study using data from The Health Improvement Network (THIN), a large UK primary care electronic health record database. We identified 196,329 mother-infant pairs in which the infant was born between 2006 and 2015. Postnatal depression was identified through antidepressant prescriptions or diagnoses or symptoms of depression in first year after childbirth. Primary outcome was completion of three 5-in-1 vaccination doses in infants before 1 year of age; this vaccine protects against diphtheria, tetanus, whooping cough, polio, and Haemophilus influenzae type b. We used Poisson regression models to compare likelihood of infant 5-in-1 vaccine uptake among children of women with a record of postnatal depression to likelihood among those without.\u0000Results: Of the 196,329 women, 20,802 (10.6%) had a record of postnatal depression and/or antidepressant prescription. There was no difference in infants' 5-in-1 vaccination completion between those of mothers with a record and those of mothers' without (adjusted incidence rate ratio [IRR] = 1.01; 95% CI, 0.99-1.02). Those from more socially deprived areas were less likely to complete infant vaccinations compared to those from the least deprived areas (IRR = 0.92; 95% CI, 0.90-0.93). Likelihood of completing infant vaccination decreased over time, comparing 2014-2015 to 2006-2007 (IRR = 0.90; 95% CI, 0.89-0.92).\u0000Conclusions: Among mothers who engage with primary care, maternal postnatal depression is not associated with lower rates of infant vaccination, though more research is needed to conclude if either more severe depression or unrecognized depression is associated with lower completion rates.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80248555","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}
Jessica S. Enns, Natalie P Mota, J. Bolton, O. Ekuma, D. Chateau, Michelle M. Paluszek, J. Sareen, L. Katz
Objective: To examine the incidence and predictors of suicide attempts and deaths in the year after psychiatric hospitalization. Methods: A population-based dataset was used to develop a cohort of individuals 18 years or older admitted with a mental disorder (defined by ICD-10 codes) from 2005 to 2016 (n = 26,975) in Manitoba, Canada. Using Cox regression, hazard ratios were calculated for each covariate among those who attempted and died by suicide in the year following hospitalization, while adjusting for confounders. Results: In the year following hospitalization for a mental disorder, 0.7% of the individuals died by suicide and 3.5% attempted suicide. Statistically significant risk factors for suicide in the year after discharge from psychiatric hospitalization included male sex (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.10-1.97) and urban location (HR, 1.37; 95% CI, 1.02-1.85) and for attempting suicide included female sex (HR, 0.63; 95% CI, 0.55-0.72), living rurally (HR, 0.66; 95% CI, 0.58-0.75), a previous mental disorder (HR, 1.63; 95% CI, 1.38-1.92), justice involvement (HR, 1.48; 95% CI, 1.28-1.70), and being on income assistance (HR, 1.17; 95% CI, 1.01-1.35) (P < .05 for all). Age (HR, 0.99; 95% CI, 0.99-0.99) (P < .05) was associated with a reduced rate of suicide attempts. Conclusions: Further research into interventions to address the identified risk factors for suicide in the recently discharged population is critical to improve management.
{"title":"Incidence and Predictors of Suicide Attempts and Suicide Deaths Among Individuals Recently Hospitalized for a Mental Disorder: A Population-Based Study.","authors":"Jessica S. Enns, Natalie P Mota, J. Bolton, O. Ekuma, D. Chateau, Michelle M. Paluszek, J. Sareen, L. Katz","doi":"10.4088/jcp.21m14055","DOIUrl":"https://doi.org/10.4088/jcp.21m14055","url":null,"abstract":"Objective: To examine the incidence and predictors of suicide attempts and deaths in the year after psychiatric hospitalization.\u0000Methods: A population-based dataset was used to develop a cohort of individuals 18 years or older admitted with a mental disorder (defined by ICD-10 codes) from 2005 to 2016 (n = 26,975) in Manitoba, Canada. Using Cox regression, hazard ratios were calculated for each covariate among those who attempted and died by suicide in the year following hospitalization, while adjusting for confounders.\u0000Results: In the year following hospitalization for a mental disorder, 0.7% of the individuals died by suicide and 3.5% attempted suicide. Statistically significant risk factors for suicide in the year after discharge from psychiatric hospitalization included male sex (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.10-1.97) and urban location (HR, 1.37; 95% CI, 1.02-1.85) and for attempting suicide included female sex (HR, 0.63; 95% CI, 0.55-0.72), living rurally (HR, 0.66; 95% CI, 0.58-0.75), a previous mental disorder (HR, 1.63; 95% CI, 1.38-1.92), justice involvement (HR, 1.48; 95% CI, 1.28-1.70), and being on income assistance (HR, 1.17; 95% CI, 1.01-1.35) (P < .05 for all). Age (HR, 0.99; 95% CI, 0.99-0.99) (P < .05) was associated with a reduced rate of suicide attempts.\u0000Conclusions: Further research into interventions to address the identified risk factors for suicide in the recently discharged population is critical to improve management.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89204000","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}
{"title":"Accumulation of Reproductive Safety Data for Second-Generation Atypical Antipsychotics: A Call to Accelerate the Process.","authors":"A. Viguera","doi":"10.4088/jcp.22com14489","DOIUrl":"https://doi.org/10.4088/jcp.22com14489","url":null,"abstract":"","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84028375","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}
{"title":"Psychiatric Patients Who Do Not Believe They Deserve to Get Better.","authors":"M. Zimmerman, Lena G Becker","doi":"10.4088/jcp.21br14314","DOIUrl":"https://doi.org/10.4088/jcp.21br14314","url":null,"abstract":"","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74774461","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}
L. Citrome, Marina Komaroff, Brittney R Starling, Sandeep Byreddy, T. Terahara, M. Hasebe
Objective: Patients with schizophrenia may exhibit symptoms of hostility. HP-3070 is the first antipsychotic patch approved by the US Food and Drug Administration (FDA) for adults with schizophrenia. Its efficacy was demonstrated in a phase 3 study. This post hoc analysis assessed the efficacy of HP-3070 in treating hostility in schizophrenia. Methods: In the pivotal phase 3 study, conducted between August 2016 and November 2017, adults with schizophrenia (per DSM-5 criteria) were randomized to HP-3070 3.8 mg/24 h, HP-3070 7.6 mg/24 h, or placebo. Least-squares mean (LSM) changes in Positive and Negative Syndrome Scale (PANSS) hostility item and PANSS-Excited Component (PANSS-EC) scores from baseline to week 6 were assessed post hoc using a mixed-effects model for repeated measures adjusted for selected PANSS-Positive symptoms and presence of somnolence or akathisia. Results: Among 442 patients with baseline PANSS hostility item score > 1 (n = 151, HP-3070 7.6 mg/24 h; n = 147, 3.8 mg/24 h; n = 144, placebo), week 6 LSM (95% CI) change from baseline (CFB) in hostility score was superior with HP-3070 versus placebo for 7.6 mg/24 h (-0.4 [-0.6 to -0.2]; P < .001) and 3.8 mg/24 h (-0.3 [-0.6 to -0.1]; P < .01), with similar results for 7.6 mg/24 h after adjusting for covariates (P < .05). For all patients regardless of baseline PANSS hostility item score, PANSS-EC week 6 LSM CFB was greater for HP-3070 7.6 mg/24 h (-1.1 [-1.9 to -0.4]; n = 203; P < .01) and 3.8 mg/24 h (-1.3 [-2.0 to -0.6]; n = 201; P < .001) than for placebo (n = 203), with similar results observed in patients with baseline hostility item score > 1. Conclusions: In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia. These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT02876900; EudraCT number: 2015-005134-21.
{"title":"Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in Adults With Schizophrenia: A Post Hoc Analysis of a 6-Week Phase 3 Study.","authors":"L. Citrome, Marina Komaroff, Brittney R Starling, Sandeep Byreddy, T. Terahara, M. Hasebe","doi":"10.4088/jcp.21m14355","DOIUrl":"https://doi.org/10.4088/jcp.21m14355","url":null,"abstract":"Objective: Patients with schizophrenia may exhibit symptoms of hostility. HP-3070 is the first antipsychotic patch approved by the US Food and Drug Administration (FDA) for adults with schizophrenia. Its efficacy was demonstrated in a phase 3 study. This post hoc analysis assessed the efficacy of HP-3070 in treating hostility in schizophrenia.\u0000Methods: In the pivotal phase 3 study, conducted between August 2016 and November 2017, adults with schizophrenia (per DSM-5 criteria) were randomized to HP-3070 3.8 mg/24 h, HP-3070 7.6 mg/24 h, or placebo. Least-squares mean (LSM) changes in Positive and Negative Syndrome Scale (PANSS) hostility item and PANSS-Excited Component (PANSS-EC) scores from baseline to week 6 were assessed post hoc using a mixed-effects model for repeated measures adjusted for selected PANSS-Positive symptoms and presence of somnolence or akathisia.\u0000Results: Among 442 patients with baseline PANSS hostility item score > 1 (n = 151, HP-3070 7.6 mg/24 h; n = 147, 3.8 mg/24 h; n = 144, placebo), week 6 LSM (95% CI) change from baseline (CFB) in hostility score was superior with HP-3070 versus placebo for 7.6 mg/24 h (-0.4 [-0.6 to -0.2]; P < .001) and 3.8 mg/24 h (-0.3 [-0.6 to -0.1]; P < .01), with similar results for 7.6 mg/24 h after adjusting for covariates (P < .05). For all patients regardless of baseline PANSS hostility item score, PANSS-EC week 6 LSM CFB was greater for HP-3070 7.6 mg/24 h (-1.1 [-1.9 to -0.4]; n = 203; P < .01) and 3.8 mg/24 h (-1.3 [-2.0 to -0.6]; n = 201; P < .001) than for placebo (n = 203), with similar results observed in patients with baseline hostility item score > 1.\u0000Conclusions: In this post hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia. These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia.\u0000Clinical Trials Registration: ClinicalTrials.gov identifier: NCT02876900; EudraCT number: 2015-005134-21.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89088096","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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