Journal of Clinical Psychopharmacology最新文献

{"title":"The Potential Benefits of Chromium and Selenium Supplementation Across Psychiatric Disorders and Symptoms.","authors":"Alessandro Di Lisi, Asia Dalla Valle, Marco Menchetti, Concetta Crisafulli, Chiara Fabbri","doi":"10.1097/JCP.0000000000002014","DOIUrl":"10.1097/JCP.0000000000002014","url":null,"abstract":"<p><strong>Background: </strong>The conception of psychiatric disorders as systemic diseases implies an important role of nutrition in mental health. Essential trace elements are present in very small amounts in the body, yet they are essential for many physiological functions.</p><p><strong>Methods: </strong>Little is known about the potential role of chromium and selenium supplementation in mental disorders and other populations. To contribute to filling this gap, this review is focused on the possible benefits of chromium and selenium, alone or in combination with pharmacological treatments, in the treatment of mental disorders or psychiatric symptoms.</p><p><strong>Results: </strong>Chromium and selenium show promising effects on psychiatric symptoms across mental disorders. Selenium may have benefits on anxious-depressive symptoms in healthy populations and groups at risk of nutritional deficits and psychiatric symptoms, for example, women in the post-partum. In addition, chromium was linked to improved insulin sensitivity and glucose metabolism, which can benefit not only metabolic health but also mood regulation, with specific benefits on atypical symptoms of depression, such as appetite/weight gain. Selenium plays a role in reducing oxidative stress and inflammation, which may suggest positive effects on psychopathology and other conditions linked to these mechanisms.</p><p><strong>Conclusions: </strong>Both trace elements may affect positively mental health and cardio-metabolic-inflammatory conditions, which have a strong link with psychiatric disorders and their prognosis. Despite the evidence is not conclusive, chromium and selenium supplementation are interesting options to investigate in future research on the personalization of treatment in mental disorders.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"376-387"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12184972/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Successful Management of Both ADHD and Its Comorbidities With Imipramine Monotherapy.","authors":"Beyza Beyazit, Beyza Nur Karal, Ali Karayağmurlu","doi":"10.1097/JCP.0000000000002009","DOIUrl":"10.1097/JCP.0000000000002009","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"397-399"},"PeriodicalIF":2.9,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What if STAR*D Had Been Placebo-Controlled? A Critical Reexamination of a Foundational Study in Depression Treatment.","authors":"Kevin P Kennedy, Jonathan P Heldt, David W Oslin","doi":"10.1097/JCP.0000000000002025","DOIUrl":"https://doi.org/10.1097/JCP.0000000000002025","url":null,"abstract":"<p><strong>Background: </strong>The STAR*D trial's sequence of dose escalation, switching, and augmentation strategies has served as a model for most depression treatment guidelines. However, STAR*D was an open-label pragmatic trial that did not use a placebo control, which complicates the assessment of its outcomes. Most STAR*D treatment steps have now been studied in blinded placebo-controlled randomized trials, which could validate STAR*D and support the growing use of pragmatic trials in depression.</p><p><strong>Methods: </strong>This review evaluates outcomes from randomized controlled trials (RCTs) for the major STAR*D treatment steps: dose increase after inadequate response to an antidepressant (Level 1), switching the antidepressant after treatment nonresponse (Levels 2 and 3), augmenting an antidepressant with bupropion or buspirone (Level 2), augmenting an antidepressant with lithium or T3 thyroid hormone (Level 3), and using combination mirtazapine-venlafaxine (Level 4).</p><p><strong>Findings: </strong>RCTs have generally not replicated the findings of STAR*D. Of the major treatment steps, there is only positive evidence for lithium augmentation and α2-antagonist-serotonin-reuptake inhibitor combination. Limitations of this review include variation in the quality and quantity of comparable RCTs for each treatment level and differences in the inclusion criteria of RCTs and STAR*D.</p><p><strong>Conclusions: </strong>These findings raise questions about the evidence supporting widely used treatment strategies following an inadequate response to an initial antidepressant. They suggest that pragmatic trials should be interpreted cautiously in the absence of blinded placebo-controlled studies and point to the need for high-quality blinded clinical trials of second-step and third-step depression treatments.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144284485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Olanzapine-Associated Hyperbilirubinemia in an Adolescent With Autistic Spectrum Disorder Comorbid With Schizophrenia: A Case Report.","authors":"Chi-Wei Ye, Chia-Heng Lin, Shin-Jie Wang","doi":"10.1097/JCP.0000000000001974","DOIUrl":"10.1097/JCP.0000000000001974","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"298-300"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143710150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Paliperidone Long-Acting Injections in Huntington's Disease.","authors":"Kamalakar Surineni, Vy Le, Kevin McKaughan, Namie Fotion","doi":"10.1097/JCP.0000000000001989","DOIUrl":"10.1097/JCP.0000000000001989","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"293-295"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143700458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Result Turnaround Time as a Crucial Factor to Increasing Clozapine Therapeutic Drug Monitoring in Hospitalized Patients.","authors":"Katelyn N Bye, Megan R Leloux, Kristin C Cole, Matej Markota, Nicholas D Allen, Paul J Jannetto, Jonathan G Leung","doi":"10.1097/JCP.0000000000001982","DOIUrl":"https://doi.org/10.1097/JCP.0000000000001982","url":null,"abstract":"<p><strong>Purpose/background: </strong>Clozapine requires careful monitoring to minimize adverse reactions and optimize response. Because of variable pharmacokinetics and interpatient variability, guidelines recommend therapeutic drug monitoring (TDM), although practical guidance is limited. This study aims to characterize patient factors associated with TDM, rates of TDM use over time, turnaround times of TDM results, and influence of institutional initiatives aimed to improve TDM.</p><p><strong>Methods/procedures: </strong>A retrospective chart review was conducted at a large 2000-bed academic medical center from August 1, 2015, to November 26, 2023. Adult patients who were administered clozapine during medical or psychiatric inpatient hospitalizations were included. Data collected included patient demographics, clozapine TDM ordering, and clozapine TDM turnaround time. Yearly TDM rates were analyzed to evaluate the impact of various institutional clozapine-related initiatives on TDM practices.</p><p><strong>Results: </strong>There were 679 encounters involving 334 patients; 62.7 % were men, and 84.4% were White. Younger patients were less likely to have levels drawn (odds ratio 0.98, confidence interval 0.97-0.99), while self-identified Asian patients more likely (odds ratio 7.54, confidence interval 1.60-35.42). TDM rates increased significantly over time for both medical (P = 0.002) and psychiatric (P < 0.001) admission types, with turnaround times improving from 66.07 hours in 2016 to 28.65 hours in 2022. Overall, TDM annual rates increased from 46.2% in 2015 to 69.6% in 2023. The time-period before and after an institutional initiative, which improved TDM turnaround time, was associated with improvements of TDM rates (36.2% vs 67.9%, P < 0.001).</p><p><strong>Conclusions: </strong>This study highlights an increase in clozapine TDM use during the study period, but use remained suboptimal. Improvement of turnaround time was associated with increased TDM rates.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":"45 3","pages":"225-230"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144180838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incorporating Real-World Treatment Data Into Clozapine's Product Label.","authors":"Larry Alphs","doi":"10.1097/JCP.0000000000001996","DOIUrl":"10.1097/JCP.0000000000001996","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"177-178"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I: A Review of the Pharmacokinetic Literature and Proposed Changes.","authors":"Jose de Leon, Ross J Baldessarini, Richard Balon, John Bilbily, Stanley N Caroff, Leslie Citrome, Christoph U Correll, Robert O Cotes, John M Davis, Lynn E DeLisi, Justin Faden, Oliver Freudenreich, David R Goldsmith, Ronald Gurrera, Richard C Josiassen, John M Kane, Deanna L Kelly, Matcheri S Keshavan, Robert S Laitman, Y W Francis Lam, Jonathan G Leung, Raymond C Love, Betsy McCollum, Ian R McGrane, Jonathan Meyer, Henry A Nasrallah, Frederick C Nucifora, Anthony J Rothschild, Jose M Rubio, Martha Sajatovic, Deepak K Sarpal, Georgios Schoretsanitis, Mujeeb Shad, Charles Shelton, Leo Sher, Balwinder Singh, Sandarsh Surya, Theodore R Zarzar, Emilio J Sanz, Carlos De Las Cuevas","doi":"10.1097/JCP.0000000000001987","DOIUrl":"10.1097/JCP.0000000000001987","url":null,"abstract":"<p><strong>Purpose/background: </strong>Clozapine was approved in the United States (US) using 1989 regulations and knowledge. After 30 years, many sections of the US package insert (PI) are outdated.</p><p><strong>Methods: </strong>We comprehensively reviewed the literature to propose PI updates. We present the information in 2 articles. In Part I, we focus on basic pharmacology based on 407 relevant articles. Part II focuses on clinical aspects and pharmacovigilance.</p><p><strong>Findings/results: </strong>Based on more recent expectations of Food and Drug Administration regulations, we reviewed clozapine basic pharmacology including the following: 1) clearance, 2) pharmacokinetics and pharmacodynamics, and 3) monitoring tools. We identified 9 major problems in the basic pharmacological sections of the PI including the following: 1) in vivo studies indicate that clozapine is dependent on CYP1A2 for its metabolism, 2) the minor role of CYP2D6 in clozapine metabolism requires removing the PI recommendation to lower clozapine doses in CYP2D6 poor metabolizers, 3) in nontoxic concentrations CYP3A4 has a minor role in clozapine metabolism and potent CYP3A4 inhibitors lack clinically relevant effects, 4) several drug-drug interactions need to be updated based on recent literature, 5) systemic inflammation may decrease clozapine metabolism and increase the risk of clozapine intoxication, 6) obesity may decrease clozapine metabolism, 7) patients of Asian and Indigenous American ancestry need lower clozapine doses, 8) personalized titration and c-reactive protein monitoring should be considered until prospective studies are available, and 9) the half-life section needs to be modified to acknowledge that single dosing at night is frequent in the US.</p><p><strong>Implications/conclusions: </strong>An improvement in the US clozapine PI may lead to improvement in PIs worldwide.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"179-196"},"PeriodicalIF":2.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12105979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Orofacial Dyskinesia in a Patient With Sotos Syndrome Treated With Methylphenidate.","authors":"Züleyha Ulusoy, Esra Hoşoğlu, Bahadır Turan","doi":"10.1097/JCP.0000000000001988","DOIUrl":"10.1097/JCP.0000000000001988","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"300-301"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143700452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navacaprant, a Novel and Highly Selective Kappa Opioid Receptor Antagonist, in Adults With Major Depressive Disorder: A Randomized, Double-Blind Phase 2 Clinical Trial.","authors":"Sanjay J Mathew, Andrew J Cutler, Nicole C Visitacion, Michael Gold, Jason Yuan, Bill Aurora","doi":"10.1097/JCP.0000000000001967","DOIUrl":"10.1097/JCP.0000000000001967","url":null,"abstract":"<p><strong>Purpose/background: </strong>This phase 2a randomized, double-blind, placebo-controlled, 8-week trial assessed the efficacy and safety of navacaprant, a highly selective kappa opioid receptor antagonist, in adults with major depressive disorder (MDD).</p><p><strong>Methods/procedures: </strong>Participants with 17-Item Hamilton Depression Rating Scale (HAMD-17) scores of 14 to 30 were randomized 1:1 to once-daily navacaprant 80 mg or placebo (n = 102 each). The primary endpoint was HAMD-17 change from baseline (CFB) to week 8. Secondary endpoints included CFB in Snaith-Hamilton Pleasure Scale (SHAPS). No adjustment for multiple comparisons was made.</p><p><strong>Findings/results: </strong>At week 8, HAMD-17 CFB was not statistically significantly improved with navacaprant vs placebo (least squares mean difference -1.7 [standard error, 1.08], P = 0.121; mixed-models repeated-measures) in the efficacy population. In a prespecified sensitivity analysis using last-observation-carried-forward, navacaprant statistically significantly improved HAMD-17 CFB (-2.9 [0.88], P = 0.002; -2.2 [0.98], P = 0.024) and SHAPS CFB (-2.8 [0.96], P = 0.004; -3.4 [1.10], P = 0.002) vs placebo at weeks 4 and 8. In the prespecified subgroup with moderate-to-severe MDD (baseline HAMD-17 score ≥22; n = 100), navacaprant statistically significantly improved HAMD-17 CFB at both timepoints (-3.0 [1.20], P = 0.015; -2.8 [1.33], P = 0.037) and SHAPS CFB at week 8 (-4.8 [1.35], P = 0.001) vs placebo. Most frequently reported adverse events (AEs) included headache (4.9% both) and nausea (4.9% navacaprant, 1.0% placebo); no serious AEs were reported with navacaprant.</p><p><strong>Implications/conclusions: </strong>Although the primary endpoint was not met in the efficacy population, which included participants with mild depression, statistically significant improvements with navacaprant on depressive symptoms including anhedonia in the moderate-to-severe MDD subgroup, along with a favorable safety profile, support further study of navacaprant for the treatment of MDD.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"267-276"},"PeriodicalIF":2.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12105956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}