Journal of Clinical Psychiatry最新文献

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Suicide Among Veterans Health Administration Patients With Bipolar Disorder: Evidence for Increased Risk Associated With Benzodiazepine Receipt. 退伍军人健康管理局双相情感障碍患者自杀:服用苯二氮卓类药物风险增加的证据
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-12 DOI: 10.4088/JCP.24m15424
Kevin G Saulnier, Anna L Philibert, Peter P Grau, Nicholas W Bowersox
{"title":"Suicide Among Veterans Health Administration Patients With Bipolar Disorder: Evidence for Increased Risk Associated With Benzodiazepine Receipt.","authors":"Kevin G Saulnier, Anna L Philibert, Peter P Grau, Nicholas W Bowersox","doi":"10.4088/JCP.24m15424","DOIUrl":"10.4088/JCP.24m15424","url":null,"abstract":"<p><p><b>Objective:</b> To evaluate factors associated with suicide mortality among Veterans Health Administration (VHA) patients with bipolar disorder.</p><p><p><b>Methods:</b> VHA patients diagnosed with bipolar disorder in calendar year (CY) 2014 who utilized VHA health care services in CY2013 were included in the study cohort. Suicide mortality in the 5 years following the first documented bipolar disorder diagnosis during CY2014 was examined using Cox proportional hazards regression.</p><p><p><b>Results:</b> 725 of 126,655 VHA patients who had a bipolar disorder diagnosis in CY2014 (0.6%) died by suicide in the following 5 CYs (2014-2019). Suicide was associated with suicide high-risk flags (hazard ratio [HR] = 2.21), prior year emergency department visit (HR = 1.25), having a new bipolar disorder diagnosis (HR= 1.23), and receiving a benzodiazepine prescription of ≥30 days of supply (HR = 1.58). Prescriptions of benzodiazepines of <30 days of supply, other anxiolytics (ie, buspirone), and sedatives were not significantly associated with suicide mortality in the multivariable model.</p><p><p><b>Conclusions:</b> Among VHA patients diagnosed with bipolar disorder, receipt of a benzodiazepine prescription of ≥30 days was associated with increased suicide risk, even after controlling for clinical and demographic factors. Elucidating mechanisms through which benzodiazepine prescriptions increase suicide risk is an important avenue for future investigations. Additionally, VHA patients with newly diagnosed bipolar disorder may benefit from increased clinical attention, given the elevated suicide risk among this subgroup. Findings highlight targets for suicide prevention initiatives.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143674779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Eating Disorders Among Transgender and Gender Diverse People: A Qualitative Analysis of Reddit Threads. 跨性别和性别多样化人群的饮食失调:Reddit帖子的定性分析。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-10 DOI: 10.4088/JCP.24com15640
Nora Y Sun, Sofia E Guerra, Alex S Keuroghlian
{"title":"Eating Disorders Among Transgender and Gender Diverse People: A Qualitative Analysis of Reddit Threads.","authors":"Nora Y Sun, Sofia E Guerra, Alex S Keuroghlian","doi":"10.4088/JCP.24com15640","DOIUrl":"https://doi.org/10.4088/JCP.24com15640","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143674710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Incidence and Risk Factors for Suicide Attempt During Pregnancy and the Postpartum Period. 妊娠和产后自杀企图的发生率和危险因素。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-05 DOI: 10.4088/JCP.24m15633
Sidra Goldman-Mellor, Mark Olfson, Alison Gemmill, Claire Margerison
{"title":"Incidence and Risk Factors for Suicide Attempt During Pregnancy and the Postpartum Period.","authors":"Sidra Goldman-Mellor, Mark Olfson, Alison Gemmill, Claire Margerison","doi":"10.4088/JCP.24m15633","DOIUrl":"10.4088/JCP.24m15633","url":null,"abstract":"<p><p></p><p><p><b>Background:</b> In the United States, suicide accounts for 1 out of every 20 deaths that occur during pregnancy and the first 12 months postpartum. Although nonfatal suicide attempts are the strongest known predictor of death by suicide, there are no prior population based estimates of the incidence of and clinical risk factors for pregnancy associated suicide attempts.</p><p><p><b>Methods:</b> This retrospective cohort study used statewide, all-payer, longitudinally linked hospital and emergency department (ED) patient records from California. Participants included all California residents with an index hospital delivery of a live infant between 2010 and 2020. Outcomes included ED presentation for nonfatal suicide attempt during pregnancy or up to 12 months postpartum. Clinical risk factors of interest included healthcare utilization patterns during pregnancy and behavioral health diagnoses recorded at index delivery.</p><p><p><b>Results:</b> Among delivering patients with an index delivery (N = 3,737,792), 0.13% (n = 4,968) had a suicide attempt during pregnancy or the postpartum period. After adjusting for background demographic characteristics, risks of a postpartum suicide attempt were increased 4- to 30-fold by several clinical factors, including prenatal suicide attempt ED visits, psychiatric ED visits, and assault ED visits, and by psychotic disorders, bipolar disorder, alcohol use disorder, recurrent and single-episode major depressive disorder, and anxiety disorders recorded at delivery.</p><p><p><b>Conclusions:</b> Risks of postpartum suicide attempt were substantially elevated for patients who had behavioral health related ED visits during pregnancy and by several psychiatric disorders at delivery. Clinical consideration should be given to monitoring these patients for suicide attempt risk.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Plasma NfL, P-tau181, and P-tau181/Aβ42 Ratio in Predicting Mild Behavioral Impairment in Dementia-Free Multiethnic Asian Older Adults With Mixed Pathology in a 5-Year Clinical Cohort. 血浆NfL、P-tau181和P-tau181/ a- β42比值在5年临床队列中预测无痴呆多种族混合病理的亚洲老年人轻度行为障碍
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-05 DOI: 10.4088/JCP.24m15558
Yingqi Liao, Joyce R Chong, Cheuk Ni Kan, Xuhao Zhao, Yuek Ling Chai, Saima Hilal, Mitchell K P Lai, Christopher P Chen, Xin Xu
{"title":"Plasma NfL, P-tau181, and P-tau181/Aβ42 Ratio in Predicting Mild Behavioral Impairment in Dementia-Free Multiethnic Asian Older Adults With Mixed Pathology in a 5-Year Clinical Cohort.","authors":"Yingqi Liao, Joyce R Chong, Cheuk Ni Kan, Xuhao Zhao, Yuek Ling Chai, Saima Hilal, Mitchell K P Lai, Christopher P Chen, Xin Xu","doi":"10.4088/JCP.24m15558","DOIUrl":"10.4088/JCP.24m15558","url":null,"abstract":"<p><p><b>Objective:</b> The underlying mechanisms of mild behavioral impairment (MBI), a marker for cognitive impairment and dementia, have remained unclear especially in a multiethnic Asian population. The study aimed to examine whether baseline Alzheimer disease biomarkers, including plasma neurofilament light (NfL) chain, phosphorylated tau-181 (p-tau181), and the p-tau181-to-amyloid-β42 (p-tau181/Aβ42) ratio, could predict MBI incidence in dementia-free Asian older adults.</p><p><p><b>Methods:</b> Participants were recruited from the community and memory clinics from August 2010 to April 2022. All participants underwent cognitive, neuropsychiatric, and clinical assessments annually and neuroimaging scans biennially at baseline and over a maximum of 5 years. Neuropsychiatric symptoms (NPS) and incident MBI were examined using Neuropsychiatric Inventory. Plasma NfL, p-tau181, and Aβ42 were measured using single molecule array assays. Neuroimaging measures of hippocampal volume (HV) and white matter hyperintensities (WMH) were obtained.</p><p><p><b>Results:</b> A total of 305 dementia-free participants were included (age 72.1 ± 7.8 years, 52.5% female, 27.9% no cognitive impairment). Among 248 MBI-free participants at baseline, 55 (25.3%) participants developed incident MBI in 5 years. Higher baseline p-tau181, p-tau181/Aβ42 ratio, and NfL were predictive of increased NPS severity longitudinally and MBI incidence (<i>P</i> < .05). Higher p-tau181 levels (hazard ratio [HR] [95% CI], 2.40 [1.00-5.75], <i>P</i> = .05) were independently associated with an increased likelihood of incident MBI after accounting for incident dementia and plasma NfL. This relationship remained significant when controlling for HV and WMH (HR [95% CI], 2.69 [1.08-6.70], <i>P</i> = .03).</p><p><p><b>Conclusions:</b> Our findings highlighted the relationship between amyloid burden and neuroaxonal degeneration with neurobehavioral changes in multiethnic Asian older adults with underlying mixed pathology.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A New Tool to Refine Lithium Therapy: A Simple Formula for a Complex Problem. 改进锂疗法的新工具:一个复杂问题的简单公式。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-03 DOI: 10.4088/JCP.24com15743
Gin S Malhi, Erica Bell, Kinga Szymaniak
{"title":"A New Tool to Refine Lithium Therapy: A Simple Formula for a Complex Problem.","authors":"Gin S Malhi, Erica Bell, Kinga Szymaniak","doi":"10.4088/JCP.24com15743","DOIUrl":"https://doi.org/10.4088/JCP.24com15743","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder. 针对重度抑郁障碍耐药发作的单剂量迷幻药长期观察随访研究的结果
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-03 DOI: 10.4088/JCP.24m15449
Guy M Goodwin, Ania Nowakowska, Merve Atli, Boadie W Dunlop, David Feifel, David J Hellerstein, Lindsey Marwood, Zainib Shabir, Sunil Mistry, Susan C Stansfield, Emma Teoh, Joyce Tsai, Matthew B Young, Ekaterina Malievskaia
{"title":"Results From a Long-Term Observational Follow-Up Study of a Single Dose of Psilocybin for a Treatment-Resistant Episode of Major Depressive Disorder.","authors":"Guy M Goodwin, Ania Nowakowska, Merve Atli, Boadie W Dunlop, David Feifel, David J Hellerstein, Lindsey Marwood, Zainib Shabir, Sunil Mistry, Susan C Stansfield, Emma Teoh, Joyce Tsai, Matthew B Young, Ekaterina Malievskaia","doi":"10.4088/JCP.24m15449","DOIUrl":"10.4088/JCP.24m15449","url":null,"abstract":"<p><p><b>Background:</b> The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP 001), compared with 10 mg and 1 mg doses. Here, we report findings from COMP 004, a 52-week observational follow-up of patients from COMP 001 and COMP 003, a small open-label study of the coadministration of 25 mg COMP360 with continuing antidepressant treatment.</p><p><p><b>Methods:</b> Adverse events (AEs) were collected over the full 52-week period. The primary efficacy endpoint was time to a prespecified depressive event over the 52 weeks following COMP360 administration in COMP 001 participants, presented as Kaplan-Meier estimates. A post hoc analysis included only participants that entered COMP 004. Data were collected from July 2020 to July 2022.</p><p><p><b>Results:</b> Sixty-six participants entered COMP 004 (COMP 001, n = 58 [25 mg group n = 22, 10 mg group n = 19, 1 mg group n = 17]; COMP 003, n = 8). Few AEs were reported post-entry into COMP 004, with 1 AE of mild suicidal ideation in the 1 mg group deemed possibly related to study drug. For all COMP 001 patients (n = 233), median time to depressive event was greater for the 25 mg group (92 days) compared to the 10 mg (83 days) and 1 mg (62 days) groups, with the majority of participants having had a depressive event by Week 12 (25 mg n = 37/75, 10 mg n = 38/79, 1 mg n = 44/75). The post hoc supplementary analysis of those who enrolled in COMP 004 from COMP 001 exhibited the difference between groups more strikingly (25 mg, 189 days; 10 mg, 43 days; 1 mg, 21 days); however, only 10 participants experienced a depressive event post-COMP 004 enrollment (25 mg n = 6, 10 mg n = 3, 1 mg n = 1) from COMP 001 and none from COMP 003. At COMP 004 entry, the 1 mg group had the highest number of participants on antidepressant medication (n = 10; 10 mg, n = 9; 25 mg, n = 6) and generally initiated treatment earlier.</p><p><p><b>Conclusion:</b> Over 52 weeks, a single administration of 25 mg psilocybin suggested longer maintenance of antidepressant effect than both 1 mg and 10 mg. Larger long-term studies are required to confirm these findings and provide clarity on the longer-term effects of psilocybin.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT04519957.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Back to the Office: The Room Where It Happens? 回到办公室:发生这种事的房间?
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-03 DOI: 10.4088/JCP.24com15710
John C Markowitz, Barbara Milrod, Timothy G Heckman, Maja Bergman, Doron Amsalem, Yuval Neria
{"title":"Back to the Office: The Room Where It Happens?","authors":"John C Markowitz, Barbara Milrod, Timothy G Heckman, Maja Bergman, Doron Amsalem, Yuval Neria","doi":"10.4088/JCP.24com15710","DOIUrl":"https://doi.org/10.4088/JCP.24com15710","url":null,"abstract":"<p><p></p><p><p></p><p><p></p><p><p></p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Estimating the 12-Hour Serum Lithium Level (eLi12): Development and Two Proof-of-Concept Studies. 估算 12 小时血清锂水平 (eLi12):开发和两项概念验证研究。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-03-03 DOI: 10.4088/JCP.24m15547
Ole Köhler-Forsberg, Anne Christine Wiuff, Torben A Devantier, Søren D Østergaard, Stephen V Faraone, Andrew A Nierenberg
{"title":"Estimating the 12-Hour Serum Lithium Level (eLi<sub>12</sub>): Development and Two Proof-of-Concept Studies.","authors":"Ole Köhler-Forsberg, Anne Christine Wiuff, Torben A Devantier, Søren D Østergaard, Stephen V Faraone, Andrew A Nierenberg","doi":"10.4088/JCP.24m15547","DOIUrl":"10.4088/JCP.24m15547","url":null,"abstract":"<p><p><b>Objective:</b> Most serum lithium (se-Li) tests do not comply with the required timing (12 hours after lithium intake). We aimed to develop an equation estimating 12-hour se-Li levels when lithium blood tests are taken at other time points than 12 hours.</p><p><p><b>Methods:</b> The equation was developed via secondary analyses using data from the Bipolar Clinical Health Outcomes Initiative in Comparative Effectiveness (CHOICE) trial and verified in 2 separate proof-of-concept studies. Bipolar CHOICE included 122 lithium-treated patients (192 se-Li measurements), who had se-Li levels measured and self-reported the time since lithium intake. The proof-of concept studies tested the accuracy of the equation by measuring se-Li concentrations at different time points up to 24 hours after lithium intake and were performed in Boston, US (5 patients, 10 se-Li measurements) and Aarhus, Denmark (21 patients, 159 se-Li measurements).</p><p><p><b>Results:</b> We present a simple equation calculating the estimated 12-hour se-Li level (eLi<sub>12</sub>) based on the measured se-Li level at the patient-reported time for intake of the last lithium dose. The accuracy was confirmed in both proof-of concept studies, where eLi<sub>12 </sub>showed a mean deviation from the 12-hour se-Li level of 10% compared to 25% for the measured se-Li (<i>P</i> < .0001). For 99 out of 102 (97%) blood tests taken between 3 and 24 hours after the last lithium dose, eLi<sub>12 </sub>was closer to the 12-hour level than the actual measured se-Li level.</p><p><p><b>Conclusion:</b> eLi<sub>12 </sub>provides clinicians with more accurate 12-hour se-Li estimations and gives patients flexibility as to when to show up for lithium blood tests.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding the Tolerability Profile of Xanomeline-Trospium Combination for the Treatment of Schizophrenia. 了解xanomelen - trospium联合治疗精神分裂症的耐受性。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-02-26 DOI: 10.4088/JCP.25com15775
Leslie Citrome
{"title":"Understanding the Tolerability Profile of Xanomeline-Trospium Combination for the Treatment of Schizophrenia.","authors":"Leslie Citrome","doi":"10.4088/JCP.25com15775","DOIUrl":"https://doi.org/10.4088/JCP.25com15775","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials. 西诺美林和氯化曲司泮治疗精神分裂症的安全性和耐受性:EMERGENT五周随机、双盲、安慰剂对照试验的汇总结果。
IF 4.5 2区 医学
Journal of Clinical Psychiatry Pub Date : 2025-02-26 DOI: 10.4088/JCP.24m15497
Inder Kaul, Amy Claxton, Sharon Sawchak, Colin Sauder, Stephen K Brannan, Edwin Raj, Shiling Ruan, George Konis, David Brown, Andrew J Cutler, Ronald Marcus
{"title":"Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials.","authors":"Inder Kaul, Amy Claxton, Sharon Sawchak, Colin Sauder, Stephen K Brannan, Edwin Raj, Shiling Ruan, George Konis, David Brown, Andrew J Cutler, Ronald Marcus","doi":"10.4088/JCP.24m15497","DOIUrl":"10.4088/JCP.24m15497","url":null,"abstract":"<p><p><b>Objective:</b> To further characterize the safety and tolerability of oral xanomeline and trospium chloride in the treatment of people with schizophrenia experiencing acute psychosis.</p><p><p><b>Methods:</b> Pooled analyses were performed on safety data from the 5-week, randomized, double-blind, placebo-controlled, inpatient EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials of xanomeline/ trospium in adults with schizophrenia with a recent worsening of psychosis requiring hospitalization. Adverse events (AEs) including extrapyramidal motor symptoms (EPS), vital signs, and clinical laboratory values were monitored. Additional analyses of AEs were conducted on subgroups based on age (<45 years or ≥45 years), sex, race (Black or White), ethnicity (Hispanic/Latino or not Hispanic/ Latino), country (United States or Ukraine), and baseline body mass index (<30 kg/m<sup>2</sup> or ≥30 kg/m<sup>2</sup>).</p><p><p><b>Results:</b> The pooled safety population comprised 683 participants from the acute trials. Discontinuation rates were similar between groups (xanomeline/ trospium, 27.6%; placebo, 22.7%). Treatment-emergent AEs were reported by 67.9% (xanomeline/trospium) and 51.3% (placebo) of participants, and 51.8% (xanomeline/trospium) and 29.4% (placebo) experienced AEs deemed related to treatment. The most common AEs with xanomeline/trospium were mild or moderate in intensity, transient, and generally gastrointestinal in nature. Subgroups demonstrated clinically nonsignificant differences in incidences of the most common AEs. Rates of EPS, somnolence, and weight gain were low in both groups.</p><p><p><b>Conclusions:</b> In pooled analyses, xanomeline/trospium was generally well tolerated in people with schizophrenia. The most common AEs were mild or moderate in intensity, transient, and consistent with the activity of xanomeline and trospium at muscarinic receptors. Rates of EPS, somnolence, and weight gain were low.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifiers: NCT03697252, NCT04659161, NCT04738123.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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