Ying Cai, Zhao Wang, Nicole Alleyne, Jami Earnest, Mary Lin, Himanshu Upadhyaya
{"title":"Pharmacokinetics of Viloxazine ER (Viloxazine Extended-Release Capsules) in Breast Milk of Healthy Lactating Women.","authors":"Ying Cai, Zhao Wang, Nicole Alleyne, Jami Earnest, Mary Lin, Himanshu Upadhyaya","doi":"10.4088/JCP.25m16169","DOIUrl":"10.4088/JCP.25m16169","url":null,"abstract":"<p><p></p><p><p><b>Objective:</b> To evaluate pharmacokinetics of viloxazine extended-release (ER) in breast milk and plasma of healthy lactating women and calculate potential infant exposure.</p><p><p><b>Methods:</b> Healthy lactating women (N=15), who were ≥12 weeks postpartum, received viloxazine ER 600 mg/d (the maximum recommended adult dose, given as 3x200 mg capsules) for 3 days at the same time each morning. Pharmacokinetic parameters describing the timing and amount of viloxazine in plasma and breast milk were measured based on samples collected predose and for 24 hours postdose on Day 3.Measures of potential infant exposure were calculated, including estimated daily infant dose (EDID) and relative infant dose (RID; the percentage of the weight-adjusted maternal daily dose that an infant would likely receive through breast milk).</p><p><p><b>Results:</b> At steady state, the median T<sub>max, milk </sub>in breast milk for viloxazine ER was 5.53 h, and the geometric mean (coefficient of variation [CV]%) breast milk-to-plasma ratio was 0.338 (17.4), indicating limited partitioning of drug into breast milk. Using a standard estimate of 150 mL/kg/d infant milk intake, the geometric mean (CV%) EDID was 0.134 (34.4) mg/kg/d, yielding an RID of 1.53% (27.6)-a value indicating low infant exposure within the commonly accepted <5%-10% RID safety threshold. Mild treatment-related adverse events were reported by 80% of participants, most commonly somnolence (67%), nausea (20%), and dizziness (20%). No participants discontinued.</p><p><p><b>Conclusion:</b> Viloxazine transfer into breastmilk of healthy, lactating women following multiple, once-daily 600 mg viloxazine ER doses was low.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT06259331.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148680857","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}
{"title":"A Growing Epidemic of Loneliness Among US Military Veterans: National Trends, Psychiatric Burden, and Suicide Risk.","authors":"Robert H Pietrzak, Ian C Fischer, Peter J Na","doi":"10.4088/JCP.26br16494","DOIUrl":"https://doi.org/10.4088/JCP.26br16494","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148680851","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}
Nicholas R Farrell, Clare C Beatty, Andreas Rhode, Mia Nuñez, Patrick B McGrath, Larry Trusky, Stephen M Smith, Jamie D Feusner
{"title":"Exposure-Based Video Therapy for Obsessive-Compulsive Disorder and Posttraumatic Stress Disorder: Clinical Outcomes From a Large Real-World Sample of Adults.","authors":"Nicholas R Farrell, Clare C Beatty, Andreas Rhode, Mia Nuñez, Patrick B McGrath, Larry Trusky, Stephen M Smith, Jamie D Feusner","doi":"10.4088/JCP.25m16180","DOIUrl":"10.4088/JCP.25m16180","url":null,"abstract":"<p><p><b>Objective:</b> Obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) are often comorbid. While exposure-based treatments can be effective for each, given that comorbid OCD and PTSD symptoms often interact dynamically, concurrent treatment may be most beneficial. The aim of the current analysis was to examine the naturalistic effectiveness of concurrently delivered exposure and response prevention (ERP) and prolonged exposure (PE) therapy among individuals with comorbid OCD and PTSD.</p><p><p><b>Methods:</b> This retrospective, observational analysis examined clinical data from adults (N=181) diagnosed with comorbid OCD and PTSD who were treated with concurrent ERP and PE through an online specialty therapy platform. PTSD symptoms were assessed using the PTSD Checklist for <i>DSM-5</i> (PCL-5) and OCD symptoms using the Dimensional Obsessive-Compulsive Scale (DOCS). Linear mixed models examined symptom change from baseline to three timepoints: (1) session 20, (2) session 40, and (3) the final assessment timepoint completed by each patient.</p><p><p><b>Results:</b> PTSD symptoms decreased from mean=43.5 (SD=14.2) at baseline to mean=26.4 (SD=17.6) at final session (Hedges <i>g</i>=1.03, 95% CI: 0.85-1.21). OCD symptoms decreased from mean=35.2 (SD=13.7) to mean=19.5 (SD=13.9) (Hedges <i>g</i>=1.16, 95% CI: 0.97-1.35). By the final session, median percent improvement was 40.9% (interquartile range [IQR]: 11.5%-70.7%) for PTSD and 50.0% (IQR: 25%-67.6%) for OCD. A total of 67.4% of patients achieved a clinically significant PTSD response (≥10-point PCL-5 reduction), 64.1% achieved a clinically significant OCD response (≥35% DOCS reduction), and 49.2% achieved a clinically significant PTSD and OCD response. Analyses of secondary treatment outcomes showed significant reductions in depressive and anxiety symptoms and disability, along with improvements in quality of life.</p><p><p><b>Conclusion:</b> Findings suggest that concurrent ERP and PE, delivered remotely via video therapy in a real-world setting, may be a clinically effective treatment approach for individuals with comorbid OCD and PTSD.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148680889","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}
Leslie Citrome, Anja Farovik, Anton M Palma, Murat Yildirim
{"title":"Effects of Brexpiprazole on Functioning in Patients With Schizophrenia Who Have Hostility and Agitation Symptoms: Post Hoc Analysis of Short- and Long-Term Trials.","authors":"Leslie Citrome, Anja Farovik, Anton M Palma, Murat Yildirim","doi":"10.4088/JCP.26m16448","DOIUrl":"10.4088/JCP.26m16448","url":null,"abstract":"<p><p><b>Objective:</b> People with schizophrenia often experience hostility and agitation, which can worsen their functioning. This post hoc analysis aimed to investigate the effects of brexpiprazole on functioning in schizophrenia in relation to hostility and agitation symptoms.</p><p><p><b>Methods:</b> Short-term data were pooled from three 6-week, randomized, double-blind, placebo-controlled trials of brexpiprazole tablets in adult inpatients with acute schizophrenia (<i>DSM-IV-TR</i> criteria), conducted at sites worldwide from July 2011 to December 2014. Long-term data were pooled from two 52-week, open-label extension trials conducted from September 2011 to February 2016. Functioning was measured using the Personal and Social Performance (PSP) scale, strengthened by removing the \"disturbing and aggressive behaviors\" domain to be independent of hostility and agitation. Participants were stratified according to baseline hostility, defined using the Positive and Negative Syndrome Scale (PANSS) hostility item, and agitation, defined using the PANSS-Excited Component subscale.</p><p><p><b>Results:</b> At baseline, 692/ 1,385 participants (50.0%) had hostility and 784 (56.6%) had agitation. At Week 6, PSP score change (least-squares mean difference [95% confidence interval]) favored brexpiprazole 2-4 mg/day versus placebo in participants with hostility (2.82 [0.58-5.07]; <i>P</i> = .014), without hostility (3.42 [1.37-5.48]; <i>P</i> = .001), and with agitation (4.05 [2.01-6.10]; <i>P</i> < .001), but not those without agitation (2.09 [-0.18 to 4.36]; <i>P</i> = .071). PSP score improved and stabilized over 58 weeks (408 participants analyzed).</p><p><p><b>Conclusion:</b> Brexpiprazole may improve functioning in adults with schizophrenia, even if they have hostility and agitation symptoms.</p><p><p><b>Trial Registration:</b> Data used in this post hoc analysis are from the following ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380, NCT01397786, and NCT01810783.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148521468","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}
Kevin P Kennedy, Ryan Bremseth-Vining, Kevin G Lynch, Nicholas Reville, Jonathan Zhang, Jasmin Moshfegh, David W Oslin
{"title":"GLP-1 Receptor Agonists and All-Cause Overdose Risk in Veterans With Type 2 Diabetes and Opioid Use Disorder.","authors":"Kevin P Kennedy, Ryan Bremseth-Vining, Kevin G Lynch, Nicholas Reville, Jonathan Zhang, Jasmin Moshfegh, David W Oslin","doi":"10.4088/JCP.25m16212","DOIUrl":"10.4088/JCP.25m16212","url":null,"abstract":"<p><p></p><p><p><b>Objective:</b> Overdoses remain a major public health challenge. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been proposed as a treatment for opioid use disorder (OUD) based on preclinical research. Early observational research suggests that GLP-1RAs are associated with reduced opioid overdoses but warrants replication in different patient populations.</p><p><p><b>Methods:</b> This target trial emulation study used Veterans Health Administration (VA) data to include Veterans with a diagnosis of type 2 diabetes mellitus and OUD who initiated semaglutide and tirzepatide or a comparison diabetes medication (insulin, metformin, a sulfonylurea, a sodium-glucose transport 2 (SGLT2) inhibitor, or a dipeptidyl-peptidase 4 [DPP4] inhibitor) between January 1, 2020, and December 31, 2024. Each set of comparison groups was propensity score matched on relevant variables. Cox proportional hazards regression models were used to compare the time to all-cause overdose events in the 12 months after medication initiation.</p><p><p><b>Results:</b> After propensity score matching, semaglutide and tirzepatide were associated with significantly lower risk of all-cause overdose compared to insulin (hazard ratio [HR]=0.32; 95% CI=0.14-0.71; <i>P</i>=.006; n=630) and SGLT2 inhibitors (HR=0.25; 95% CI=0.09-0.68; <i>P</i>=.006; n=432). Semaglutide and tirzepatide were not associated with significantly lower risks than metformin (HR=0.75; 95% CI=0.38-1.45; n=1,016), sulfonylureas (HR=0.82; 95% CI=0.33-1.96; n=710), or DPP4 inhibitors (HR=1.20; 95% CI=0.52-2.78; n=858).</p><p><p><b>Conclusion:</b> Collectively, semaglutide and tirzepatide were associated with lower risk of all-cause overdose compared to insulin and SGLT2 inhibitors, but not metformin, sulfonylureas, or DPP4 inhibitors. These results suggest the possible role of GLP-1RAs in OUD but underscore the need for randomized controlled trials.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13527612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148521496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vasilis C Hristidis, Victoria De Leon, Andrew D Van Der Vaart, Harold A Sackeim, A John Rush, Scott T Aaronson, Mark T Bunker, Rebecca M Allen, Yvette Sheline, Ziad Nahas, David L Dunner, Britt M Gott, Ying-Chieh Lee, Charles Gordon, Quyen Tran, Olivia Shy, João Quevedo, Patricio Riva-Posse, John Zajecka, Brian J Mickey, Walter Duffy, Christopher L Kriedt, Maria A Oquendo, Charles R Conway
{"title":"Impact of Vagus Nerve Stimulation on Suicidal Ideation in Markedly Treatment-Resistant Major Depression: A RECOVER Study Report.","authors":"Vasilis C Hristidis, Victoria De Leon, Andrew D Van Der Vaart, Harold A Sackeim, A John Rush, Scott T Aaronson, Mark T Bunker, Rebecca M Allen, Yvette Sheline, Ziad Nahas, David L Dunner, Britt M Gott, Ying-Chieh Lee, Charles Gordon, Quyen Tran, Olivia Shy, João Quevedo, Patricio Riva-Posse, John Zajecka, Brian J Mickey, Walter Duffy, Christopher L Kriedt, Maria A Oquendo, Charles R Conway","doi":"10.4088/JCP.25m16296","DOIUrl":"10.4088/JCP.25m16296","url":null,"abstract":"<p><p></p><p><p><b>Objective:</b> To compare effects of adjunctive active versus sham vagus nerve stimulation (VNS) on suicidal ideation (SI) in markedly treatment-resistant depression (TRD).</p><p><p><b>Methods:</b> RECOVER trial participants with nonpsychotic major depressive disorder and insufficient benefit from ≥4 adequate antidepressant trials in the current episode were randomized to adjunctive active or sham VNS plus treatment as usual over 12 months. SI was assessed at baseline and monthly (months 3-12) following VNS parameter titration/ pseudotitration. A composite suicidal ideation (CSI) score (range, 0-9) used SI items from 3 depressive symptom ratings to assess VNS effects on SI for those with (CSI ≥3) and without (CSI ≤2) significant baseline SI.</p><p><p><b>Results:</b> This exploratory study involved a sample (N = 463) who averaged 13.3 failed lifetime antidepressant treatments, with 17.7 years in the current depressive episode; 40.4% had previously attempted suicide. Among individuals with baseline SI, the likelihood of meaningful improvement (CSI score change ≥3) was greater with active than sham VNS (odds ratio [OR] = 1.43; 95% CI, 1.004-2.021; <i>P</i> < .05) over 10 months of evaluation. Additionally, active VNS was superior to sham VNS for SI remission (CSI ≤2) in months 10-12 (OR = 1.67; 95% CI, 1.007-2.763; <i>P</i> < .05). VNS did not significantly worsen SI in participants.</p><p><p><b>Conclusions:</b> This study suggests that, compared to sham VNS, active VNS reduces SI and potentially induces SI remission among participants with chronic TRD and baseline SI. Furthermore, VNS does not appear to worsen or induce SI in participants, regardless of their baseline SI status. Further research is warranted.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT03887715.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148450355","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}
{"title":"GLP-1 Receptor Agonists for Non-obese Asian Patients With Schizophrenia: Beyond the Body Mass Index Paradigm.","authors":"Takahiko Nagamine","doi":"10.4088/JCP.26lr16549","DOIUrl":"https://doi.org/10.4088/JCP.26lr16549","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148450377","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}
{"title":"Psychiatrists and Medical Aid in Dying: Entering Uncharted Waters.","authors":"Jacob M Appel","doi":"10.4088/JCP.26com16382","DOIUrl":"10.4088/JCP.26com16382","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148363629","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}
{"title":"Generative AI for the Clinical Psychopharmacologist: Is It Ready for Prime Time?","authors":"Ritvij Satodiya","doi":"10.4088/JCP.26ac16486","DOIUrl":"10.4088/JCP.26ac16486","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 4","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148363658","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}
Ali Imam Awan, Eslam Elhossieny, Ali Zubair, Muhammad Arham, Nida Waheed, Elizabeth Zharovsky, Haitham Salem
{"title":"Mind and Metabolism in Crisis: US Mortality Involving Obesity and Psychiatric Disorders-Trends, Disparities, and ARIMA Projections.","authors":"Ali Imam Awan, Eslam Elhossieny, Ali Zubair, Muhammad Arham, Nida Waheed, Elizabeth Zharovsky, Haitham Salem","doi":"10.4088/JCP.26m16430","DOIUrl":"10.4088/JCP.26m16430","url":null,"abstract":"<p><p></p><p><p><b>Background:</b> Obesity and psychiatric disorders are major contributors to morbidity and premature mortality in the US and frequently co-occur, yet their joint mortality burden has not been systematically quantified nationally.</p><p><p><b>Methods:</b> We conducted a retrospective population-based study of adults aged ≥25 years using the CDC WONDER Multiple Cause of Death database (1999-2023). Deaths were identified using <i>ICD-10</i> codes for obesity (E66) and psychiatric disorders (F01-F99). Age-adjusted mortality rates (AAMRs) were calculated, and trends were assessed using joinpoint regression to estimate annual percent change (APC). Future trends through 2030 were forecasted using autoregressive integrated moving average (ARIMA) modeling. Sociodemographic and geographic disparities were examined using multivariable Poisson regression, reporting incidence rate ratios (IRRs).</p><p><p><b>Results:</b> A total of 195,180 deaths were identified. AAMRs increased from 6.0 to 82.2 per million between 1999-2021, then declined to 66.6 per million in 2023. The steepest increases occurred in 1999-2005 (APC=+19.2%) and 2018-2021 (APC=+20.6%). Substance use disorders showed the highest burden (AAMR=29.8), followed by mood (2.6), organic (2.2), and psychotic (1.0) disorders. Mortality was higher in males (IRR=1.41) and adults aged 65-74 years (IRR=8.34). Per-capita mortality was highest among American Indian/Alaska Native populations and lowest among Asian individuals (IRR=0.09). ARIMA projected a rebound to 74.2 per million by 2030.</p><p><p><b>Conclusion:</b> Co-occurring obesity and psychiatric disorders are associated with rising and inequitable mortality in the US, underscoring the need for integrated obesity care, metabolic monitoring, and targeted substance use interventions.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148363627","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}