Journal of Psychiatric Practice最新文献

{"title":"How the Food and Drug Administration Drug Approval Process Relates to the Potential Approval of Intravenous Racemic Ketamine for Treatment-resistant Major Depression.","authors":"Sheldon H Preskorn","doi":"10.1097/PRA.0000000000000768","DOIUrl":"10.1097/PRA.0000000000000768","url":null,"abstract":"<p><p>This column focuses on the status of intravenous racemic ketamine for the treatment of patients suffering from a form of major depressive disorder that does not respond to trials of currently available biogenic amine antidepressants. To provide context, the column reviews the 3 pivotal elements of the usual Food and Drug Administration (FDA) drug approval process: (1) the unmet medical need (ie, the indication) for which the drug is being developed, (2) the efficacy of the drug for that condition, and (3) the safety/tolerability of the drug. This column is based on the author's 45-year history of drug development work and is not a statement of the FDA. There are typically 3 phases in the drug development process: (1) studies done in normal volunteers, (2) typically small-scale proof of concept studies, and (3) large-scale registration trials. This third phase is critical in determining the efficacy, safety, and tolerability of the drug in a manner that most closely follows the clinical use of the drug. This column focuses specifically on whether generally small-scale studies done in academic centers are sufficient for drug approval, and it briefly reviews lithium and clozapine as examples of psychiatric medications that had such academic research in the literature, as well as clinical use in other countries. Those data supported the unique value of these medications in patients with bipolar disorder and treatment-resistant schizophrenia (ie, the unmet medical need), respectively, and the findings led American psychiatrists to advocate for FDA approval of these medications. Their efforts led to the needed registration trials for FDA approval of these medications. This column reviews the key features of registration trials and the reason that they are critical for FDA approval, and it discusses 2 special considerations related to the intravenous administration of racemic ketamine. First, racemic ketamine is not esketamine but, instead, it contains R-ketamine in addition to S-ketamine (ie, esketamine). The second consideration is that differences between intravenous and intranasal administration may affect the safety of the drug. While safety concerns were specifically addressed in the registration trials for esketamine, comparable research remains to be done for intravenous racemic ketamine. Understanding how the FDA's drug approval process works is important for prescribers, their patients, and the public.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"134-138"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulary Coverage of Esketamine and Ketamine for Depression in Ohio Health Insurance Marketplace and Medicaid Plans.","authors":"Brian S Barnett","doi":"10.1097/PRA.0000000000000766","DOIUrl":"10.1097/PRA.0000000000000766","url":null,"abstract":"<p><p>For more than 2 decades, intravenous ketamine has been demonstrated to have rapid antidepressant effects. However, access to this generic drug is limited due to insurers claiming it is \"experimental\" because ketamine does not have a Food and Drug Administration indication for depression. In contrast, intranasal esketamine, an enantiomer of ketamine, is approved by the Food and Drug Administration for depression and is still under patent. The goal of this column is to provide a clearer understanding of formulary coverage of these similar medications by insurers. Formularies of all 2023 Ohio Health Insurance Marketplace and Medicaid plans were reviewed to determine the inclusion status of intravenous ketamine and intranasal esketamine for depression. This review found that intravenous ketamine was not covered by any Marketplace or Medicaid plan for depression, while intranasal esketamine was on 72.7% and 100% of formularies, respectively. Thus, members of the analyzed insurance plans can more easily access intranasal esketamine than intravenous ketamine for depression, despite the latter being more cost-effective and possibly more efficacious.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"130-133"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prodromal or Factitious Psychosis: A Cautionary Tale in the Era of Increasing Social Media Use by Vulnerable Individuals.","authors":"Leo Bastiaens, Stephanie Cristofano-Casella, Jesse Bastiaens","doi":"10.1097/PRA.0000000000000771","DOIUrl":"10.1097/PRA.0000000000000771","url":null,"abstract":"<p><p>Research on the prodromal phase of schizophrenia has been ongoing for several decades and, more recently, findings from this research are being incorporated into everyday psychiatric practice, such as the use of interviews to evaluate prodromal symptomatology. This evolution is happening in the midst of an explosion of social media use by teenagers and young adults, increasing the exposure of youth to portrayals of psychiatric experiences. For example, reports from around the world of \"TIK-TOK tics\" emphasize the role of social media in the \"creation\" of psychiatric symptoms. This case report highlights the importance of a full psychiatric evaluation in acute care settings where quick treatment of psychotic symptoms is the norm. A 15-year-old patient was initially diagnosed with prodromal schizophrenia but, after a more extensive evaluation during a second admission, she was diagnosed with borderline personality disorder. Her antipsychotic treatment regimen was stopped and appropriate education and treatment were started, without the recurrence of \"psychotic symptoms\" during follow-up. It may be that patients with borderline personality disorder, a frequent condition on inpatient units, are at particular risk of assimilating symptoms as represented on social media.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"162-166"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acknowledgment of Peer Reviewers.","authors":"","doi":"10.1097/PRA.0000000000000777","DOIUrl":"https://doi.org/10.1097/PRA.0000000000000777","url":null,"abstract":"","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"169"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patterns of Psychiatric Medication Prescriptions for Veterans in Treatment Courts and Other Specialty Courts.","authors":"Jack Tsai, Nicholaus J Christian, Dorota Szymkowiak","doi":"10.1097/PRA.0000000000000769","DOIUrl":"10.1097/PRA.0000000000000769","url":null,"abstract":"<p><p>Psychiatric medications can serve as important tools for addressing behavioral health issues among criminal justice-involved (CJI) veterans. This study used national data on 12,790 CJI veterans in the U.S. Department of Veterans Affairs (VA) Veterans Justice Outreach program from 2019 to 2020 to compare patterns of psychiatric medication prescriptions among veterans who entered a veterans treatment court (n = 6975), another specialty court (SC; n = 414), or no-SC (n = 5401). Different classes of medications were examined, including antidepressants, stimulants, antipsychotics, benzodiazepines, and medications for substance use disorders. The results showed that 60.2% of the total sample was prescribed a psychiatric medication within 1 year of entering the Veterans Justice Outreach program. There was no significant difference in overall psychiatric prescribing among veterans treatment court, other SC, and no-SC groups, but there were a few differences in certain classes of psychiatric medications. Moreover, about 7.8% of veterans who were in the no-SC group and were prescribed psychiatric medications did not have a psychiatric diagnosis. Veterans who were younger, non-Hispanic white, married, with a VA service-connected disability rating, had a diagnosis of mental and/or substance use disorder, and used more VA health care services were more likely to have been prescribed psychiatric medication. Together, these findings illustrate the essential role of psychiatric medications in courts and programs that serve CJI veterans, as well as the important link between VA service engagement and psychiatric prescriptions.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"119-129"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The American Psychiatric Association Publishing Textbook of Geriatric Psychiatry, Sixth Edition.","authors":"Matthew J Biller, Art Walaszek","doi":"10.1097/PRA.0000000000000765","DOIUrl":"10.1097/PRA.0000000000000765","url":null,"abstract":"","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"167-168"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Moral Dimension of Mental Health Treatment.","authors":"John R Peteet","doi":"10.1097/PRA.0000000000000775","DOIUrl":"10.1097/PRA.0000000000000775","url":null,"abstract":"<p><p>Patients regularly bring value-laden concerns to treatment, but clinicians are often unsure about what role to play in their patients' moral lives. Addressing problems in moral functioning depends on assessing how individuals are accomplishing basic moral tasks: developing moral commitments, making moral decisions, implementing these decisions, assessing the correspondence between their ideals and behavior, dealing effectively with moral failure, and developing morally admirable character traits, or virtues. Clarity about the moral dimension of clinical work is important for shaping the direction of treatment, achieving clinical aims, and engaging the moral challenges that clinicians face.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"157-161"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Attunement.","authors":"John M Oldham","doi":"10.1097/PRA.0000000000000774","DOIUrl":"10.1097/PRA.0000000000000774","url":null,"abstract":"","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 2","pages":"81"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of Psychiatric Inpatients: The Role of Gender Differences in Clinical and Pharmacological Patterns.","authors":"Isabella Berardelli, Andrea Aguglia, Andrea Amerio, Salvatore Sarubbi, Elena Rogante, Maria A Trocchia, Davide Zelletta, Ludovica Longhini, Denise Erbuto, Fabrizio Pastorino, Dorian A Lamis, Marco Innamorati, Gianluca Serafini, Maurizio Pompili","doi":"10.1097/PRA.0000000000000756","DOIUrl":"10.1097/PRA.0000000000000756","url":null,"abstract":"<p><strong>Background: </strong>Severe mental disorders that require hospitalization are disabling conditions that contribute to the burden of mental diseases. They pose increased clinical challenges and highlight the need to thoroughly explore variables emerging from daily clinical practice. In this study, we assessed to what extent gender differences may characterize a large population of psychiatric inpatients.</p><p><strong>Methods: </strong>We conducted a cross-sectional study in 2 Italian teaching medical centers, which included 2358 patients who were consecutively admitted to the psychiatric emergency units. We explored and characterized gender differences for variables such as prevalence of psychiatric diagnosis, presence of suicidal ideation, suicide attempts, age at onset of psychiatric illness, presence of substance or alcohol abuse, length of stay, number of hospitalizations, presence of involuntary admission, type of discharge from the hospital, and pharmacological treatment at discharge.</p><p><strong>Results: </strong>Female patients were primarily diagnosed with bipolar disorder or personality disorders. Female patients had a significantly higher prevalence of lifetime suicide attempts (23.1% vs. 16.5%, P<0.001) and a longer length of hospitalization (11.43±10.73 d vs. 10.52±10.37 d, t=-2.099, gl=2356, P=0.036) compared with male patients. Male patients had more involuntary admissions (25.1% vs. 19.7%, χ2=9.616, gl=1, P=0.002), more use of illicit substances (34.1% vs. 20.9%, χ2=51.084, gl=1, P<0.001), and higher rates of alcohol abuse (21.3% vs. 14.7%, χ2=17.182, gl=1, P<0.001) compared with female patients. Finally, antidepressants and lithium were prescribed more frequently to the female patients, whereas other mood stabilizers were more often prescribed to the male patients.</p><p><strong>Conclusions: </strong>Our real-world results highlighted gender differences among patients with severe mental disorders admitted to psychiatric units, and suggest further investigations that may help in understanding trajectories accompanying disabling clinical conditions.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 1","pages":"2-12"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139478608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient and Caregiver Depression in Jordan After a First Stroke.","authors":"Belal Aldabbour, Majdi Al Qawasmeh, Samah Elamassie, Amal Abuabada, Khalid Abdelrahman, Mohammad Zahran, Mays Khweileh, Khalid El-Salem","doi":"10.1097/PRA.0000000000000754","DOIUrl":"10.1097/PRA.0000000000000754","url":null,"abstract":"<p><strong>Background: </strong>Poststroke depression among patients is well-recognized, while caregiver depression is understudied. The interaction between patient and caregiver depression is also unclear.</p><p><strong>Methods: </strong>This cross-sectional and follow-up study recruited 108 patient-caregiver dyads after the first-ever stroke. Demographic and clinical data, stroke severity (NIH Stroke Scale score), functional outcome (Barthel Index), and residual disability (modified Rankin Score) were documented. Using the self-reported Patient Health Questionnaire-9, we screened patients and caregivers for depressive symptoms upon admission and after 1 month. Changes in the prevalence and severity of depression were calculated. The Pearson correlation test and logistic regression analysis were conducted to evaluate both the correlation between both groups and significant predictors of depression.</p><p><strong>Results: </strong>In total, 89 patients and 96 caregivers responded to both screenings. Depression was reported by 13.5% and 27.0% of patients on admission and after 1 month, and 9.4% and 18.8% of caregivers, respectively. Caregiver depression on admission was significantly correlated with patient depression on admission (P=0.031). In addition, depression in caregivers after 1 month was a significant predictor of patient depression (P=0.008). Predictors of caregiver depression after 1 month were female caregivers (P=0.026), caring for a male patient (P=0.045), higher mRS scores after 1 month (P=0.013), longer admissions (P=0.017), caregiver between 17 and 35 years of age compared with 54 to 70 years of age (P=0.030), and caring for a patient with poststroke depression at 1 month poststroke (P=0.003).</p><p><strong>Conclusions: </strong>Both stroke survivors and their caregivers are at high risk for depression, with a potential interaction between depression in the 2 groups.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":"30 1","pages":"51-61"},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139478620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}