International Journal of Neuropsychopharmacology最新文献

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Blunted Cortisol Response to Acute Psychosocial Stress in Women With Premenstrual Dysphoric Disorder. 患有经前期焦虑症的女性对急性社会心理压力的皮质醇反应减弱。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-03-01 DOI: 10.1093/ijnp/pyae015
Ajna Hamidovic, John Davis, Fatimata Soumare
{"title":"Blunted Cortisol Response to Acute Psychosocial Stress in Women With Premenstrual Dysphoric Disorder.","authors":"Ajna Hamidovic, John Davis, Fatimata Soumare","doi":"10.1093/ijnp/pyae015","DOIUrl":"10.1093/ijnp/pyae015","url":null,"abstract":"<p><strong>Background: </strong>Despite being considered a stress-related condition, it is not known whether the hypothalamic-pituitary-adrenal (HPA) axis is dysfunctional in response to acute psychosocial stress in premenstrual dysphoric disorder (PMDD). This is problematic because many women with PMDD report that they are not able to control their stress levels, and a blunted cortisol output has been identified in women with related psychiatric conditions, such as anxiety and depression. The present study is a part of the Premenstrual Hormonal and Affective State Evaluation (PHASE) project, and it aimed to characterize the cortisol trajectory in response to an acute psychosocial stress challenge.</p><p><strong>Methods: </strong>Women with PMDD and healthy controls with confirmed ovulatory cycles underwent the Trier Social Stress Test (TSST) procedure in the mid-late luteal phase of the menstrual cycle, throughout which we collected serum samples of cortisol that we analyzed using ultra-performance liquid chromatography tandem mass spectrometry.</p><p><strong>Results: </strong>The linear mixed model analysis indicated a significant time*diagnosis interaction (P = .008) such that women with PMDD displayed significantly lower serum cortisol levels at +40 through +90 minutes from the time of stress induction.</p><p><strong>Conclusion: </strong>This is the first study to show that women with PMDD have a blunted cortisol response to psychosocial stress. Combined with our earlier finding showing a greater parasympathetic nervous system withdrawal on heart oscillations in PMDD during acute stress, these and other results show that the dysregulated processing of stress in PMDD may be captured using objective study measures.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10965026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140059341","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}
引用次数: 0
Enhanced Risky Choice in Male Rats Elicited by the Acute Pharmacological Stressor Yohimbine Involves Prefrontal Dopamine D1 Receptor Activation. 雄性大鼠在急性药理应激物育亨宾的作用下做出更危险的选择涉及前额叶多巴胺 D1 受体的激活。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae006
Alexandra Münster, Julia Huster, Susanne Sommer, Corinna Traxler, Angeline Votteler, Wolfgang Hauber
{"title":"Enhanced Risky Choice in Male Rats Elicited by the Acute Pharmacological Stressor Yohimbine Involves Prefrontal Dopamine D1 Receptor Activation.","authors":"Alexandra Münster, Julia Huster, Susanne Sommer, Corinna Traxler, Angeline Votteler, Wolfgang Hauber","doi":"10.1093/ijnp/pyae006","DOIUrl":"10.1093/ijnp/pyae006","url":null,"abstract":"<p><strong>Background: </strong>Acute stress alters risk-based decision-making; however, the underlying neural and neurochemical substrates are underexplored. Given their well-documented stress-inducing effects in humans and laboratory animals, glucocorticoids such as cortisol and corticosterone and the α2-adrenoceptor antagonist yohimbine represent potent pharmacological tools to mimic some characteristics of acute stress.</p><p><strong>Methods: </strong>Here, we analyzed the effects of the pharmacological stressors corticosterone and yohimbine given systemically on risk-based decision-making in male rats. Moreover, we investigated whether pharmacological stressor effects on risk-based decision-making involve dopamine D1 receptor stimulation in the dorsal prelimbic cortex (PL). We used a risk discounting task that requires choosing between a certain/small reward lever that always delivered 1 pellet and a risky/large reward lever that delivered 4 pellets with a decreasing probability across subsequent trials.</p><p><strong>Results: </strong>Systemic administration of yohimbine increased the preference for the risky/large reward lever. By contrast, systemic single administration of corticosterone did not significantly promote risky choice. Moreover, co-administration of corticosterone did not enhance the effects of yohimbine on risky choice. The data further show that the increased preference for the risky/large reward lever under systemic yohimbine was lowered by a concurrent pharmacological blockade of dopamine D1 receptors in the PL.</p><p><strong>Conclusions: </strong>Our rodent data provide causal evidence that stimulation of PL D1 receptors may represent a neurochemical mechanism by which the acute pharmacological stressor yohimbine, and possibly nonpharmacological stressors as well, promote risky choice.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10852621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139424639","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}
引用次数: 0
Making Sense of Psychedelics in the CNS. 了解中枢神经系统中的迷幻剂。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae007
Blake A Fordyce, Bryan L Roth
{"title":"Making Sense of Psychedelics in the CNS.","authors":"Blake A Fordyce, Bryan L Roth","doi":"10.1093/ijnp/pyae007","DOIUrl":"10.1093/ijnp/pyae007","url":null,"abstract":"<p><p>For centuries, ancient lineages have consumed psychedelic compounds from natural sources. In the modern era, scientists have since harnessed the power of computational tools, cellular assays, and behavioral metrics to study how these compounds instigate changes on molecular, cellular, circuit-wide, and system levels. Here, we provide a brief history of psychedelics and their use in science, medicine, and culture. We then outline current techniques for studying psychedelics from a pharmacological perspective. Finally, we address known gaps in the field and potential avenues of further research to broaden our collective understanding of physiological changes induced by psychedelics, the limits of their therapeutic capabilities, and how researchers can improve and inform treatments that are rapidly becoming accessible worldwide.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10888522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139642111","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}
引用次数: 0
Divergent Acute and Enduring Changes in 50-kHz Ultrasonic Vocalizations in Rats Repeatedly Treated With Amphetamine and Dopaminergic Antagonists: New Insights on the Role of Dopamine in Calling Behavior. 用苯丙胺和多巴胺能拮抗剂反复治疗大鼠50千赫兹超声波发声的急性和持久性差异变化:多巴胺在呼叫行为中作用的新见解。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae001
Marcello Serra, Giulia Costa, Emmanuel Onaivi, Nicola Simola
{"title":"Divergent Acute and Enduring Changes in 50-kHz Ultrasonic Vocalizations in Rats Repeatedly Treated With Amphetamine and Dopaminergic Antagonists: New Insights on the Role of Dopamine in Calling Behavior.","authors":"Marcello Serra, Giulia Costa, Emmanuel Onaivi, Nicola Simola","doi":"10.1093/ijnp/pyae001","DOIUrl":"10.1093/ijnp/pyae001","url":null,"abstract":"<p><strong>Background: </strong>Rats emit 50-kHz ultrasonic vocalizations (USVs) in response to nonpharmacological and pharmacological stimuli, with addictive psychostimulants being the most effective drugs that elicit calling behavior in rats. Earlier investigations found that dopamine D1-like and D2-like receptors modulate the emission of 50-kHz USVs stimulated in rats by the acute administration of addictive psychostimulants. Conversely, information is lacking on how dopamine D1-like and D2-like receptors modulate calling behavior in rats that are repeatedly treated with addictive psychostimulants.</p><p><strong>Methods: </strong>We evaluated the emission of 50-kHz USVs in rats repeatedly treated (×5 on alternate days) with amphetamine (1 mg/kg, i.p.) either alone or together with (1) SCH 23390 (0.1-1 mg/kg, s.c.), a dopamine D1 receptor antagonist; (2) raclopride (0.3-1 mg/kg, s.c.), a selective dopamine D2 receptor antagonist; or (3) a combination of SCH 23390 and raclopride (0.1 + 0.3 mg/kg, s.c.). Calling behavior of rats was recorded following pharmacological treatment, as well as in response to the presentation of amphetamine-paired cues and to amphetamine challenge (both performed 7 days after treatment discontinuation).</p><p><strong>Results: </strong>Amphetamine-treated rats displayed a sensitized 50-kHz USV emission during repeated treatment, as well as marked calling behavior in response to amphetamine-paired cues and to amphetamine challenge. Antagonism of D1 or D2 receptors either significantly suppressed or attenuated the emission of 50-kHz USVs in amphetamine-treated rats, with a maximal effect after synergistic antagonism of both receptors.</p><p><strong>Conclusions: </strong>These results shed further light on how dopamine transmission modulates the emission of 50-kHz USVs in rats treated with psychoactive drugs.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10852626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139086853","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}
引用次数: 0
Ketone Supplementation Dampens Subjective and Objective Responses to Alcohol: Evidence From a Preclinical Rat Study and a Randomized, Cross-Over Trial in Healthy Volunteers. 补充酮可抑制对酒精的主观和客观反应:来自临床前大鼠研究和健康志愿者随机交叉试验的证据。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae009
Xinyi Li, Zhenhao Shi, Dustin R Todaro, Timothy Pond, Juliana I Byanyima, Sianneh A Vesslee, Rishika Reddy, Ravi Prakash Reddy Nanga, Gabriel Kass, Vijay Ramchandani, Henry R Kranzler, Janaina C M Vendruscolo, Leandro F Vendruscolo, Corinde E Wiers
{"title":"Ketone Supplementation Dampens Subjective and Objective Responses to Alcohol: Evidence From a Preclinical Rat Study and a Randomized, Cross-Over Trial in Healthy Volunteers.","authors":"Xinyi Li, Zhenhao Shi, Dustin R Todaro, Timothy Pond, Juliana I Byanyima, Sianneh A Vesslee, Rishika Reddy, Ravi Prakash Reddy Nanga, Gabriel Kass, Vijay Ramchandani, Henry R Kranzler, Janaina C M Vendruscolo, Leandro F Vendruscolo, Corinde E Wiers","doi":"10.1093/ijnp/pyae009","DOIUrl":"10.1093/ijnp/pyae009","url":null,"abstract":"<p><strong>Background: </strong>Previous preclinical and human studies have shown that a high-fat ketogenic diet and ketone supplements (KS) are efficacious in reducing alcohol craving, alcohol consumption, and signs of alcohol withdrawal. However, the effects of KS on alcohol sensitivity are unknown.</p><p><strong>Methods: </strong>In this single-blind, cross-over study, 10 healthy participants (3 females) were administered a single, oral dose of a KS (25 g of ketones from D-β-hydroxybutyric acid and R-1,3-butanediol) or placebo 30 minutes before an oral alcohol dose (0.25 g/kg for women; 0.31 g/kg for men). Assessments of breath alcohol concentration and blood alcohol levels (BAL) and responses on the Drug Effect Questionnaire were repeatedly obtained over 180 minutes after alcohol consumption. In a parallel preclinical study, 8 Wistar rats (4 females) received an oral gavage of KS (0.42 g ketones/kg), water, or the sweetener allulose (0.58 g/kg) followed 15 minutes later by an oral alcohol dose (0.8 g/kg). BAL was monitored for 240 minutes after alcohol exposure.</p><p><strong>Results: </strong>In humans, the intake of KS before alcohol significantly blunted breath alcohol concentration and BAL, reduced ratings of alcohol liking and wanting more, and increased disliking for alcohol. In rats, KS reduced BAL more than either allulose or water.</p><p><strong>Conclusion: </strong>KS altered physiological and subjective responses to alcohol in both humans and rats, and the effects were likely not mediated by the sweetener allulose present in the KS drink. Therefore, KS could potentially reduce the intoxicating effects of alcohol.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10901540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691766","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}
引用次数: 0
PI3K-AKT/mTOR Signaling in Psychiatric Disorders: A Valuable Target to Stimulate or Suppress? 精神疾病中的 PI3K-AKT/mTOR 信号:是刺激还是抑制的重要目标?
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae010
Yan Chen, Wei Guan, Mei-Lan Wang, Xiao-Yun Lin
{"title":"PI3K-AKT/mTOR Signaling in Psychiatric Disorders: A Valuable Target to Stimulate or Suppress?","authors":"Yan Chen, Wei Guan, Mei-Lan Wang, Xiao-Yun Lin","doi":"10.1093/ijnp/pyae010","DOIUrl":"10.1093/ijnp/pyae010","url":null,"abstract":"<p><p>Economic development and increased stress have considerably increased the prevalence of psychiatric disorders in recent years, which rank as some of the most prevalent diseases globally. Several factors, including chronic social stress, genetic inheritance, and autogenous diseases, lead to the development and progression of psychiatric disorders. Clinical treatments for psychiatric disorders include psychotherapy, chemotherapy, and electric shock therapy. Although various achievements have been made researching psychiatric disorders, the pathogenesis of these diseases has not been fully understood yet, and serious adverse effects and resistance to antipsychotics are major obstacles to treating patients with psychiatric disorders. Recent studies have shown that the mammalian target of rapamycin (mTOR) is a central signaling hub that functions in nerve growth, synapse formation, and plasticity. The PI3K-AKT/mTOR pathway is a critical target for mediating the rapid antidepressant effects of these pharmacological agents in clinical and preclinical research. Abnormal PI3K-AKT/mTOR signaling is closely associated with the pathogenesis of several neurodevelopmental disorders. In this review, we focused on the role of mTOR signaling and the related aberrant neurogenesis in psychiatric disorders. Elucidating the neurobiology of the PI3K-AKT/mTOR signaling pathway in psychiatric disorders and its actions in response to antidepressants will help us better understand brain development and quickly identify new therapeutic targets for the treatment of these mental illnesses.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10888523/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139746622","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}
引用次数: 0
A Systematic Review of the Molecular and Cellular Alterations Induced by Cannabis That May Serve as Risk Factors for Bipolar Disorder. 大麻诱发的分子和细胞变化可能成为躁郁症风险因素的系统回顾。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae002
Alejandra Delgado-Sequera, Clara Garcia-Mompo, Ana Gonzalez-Pinto, Maria Hidalgo-Figueroa, Esther Berrocoso
{"title":"A Systematic Review of the Molecular and Cellular Alterations Induced by Cannabis That May Serve as Risk Factors for Bipolar Disorder.","authors":"Alejandra Delgado-Sequera, Clara Garcia-Mompo, Ana Gonzalez-Pinto, Maria Hidalgo-Figueroa, Esther Berrocoso","doi":"10.1093/ijnp/pyae002","DOIUrl":"10.1093/ijnp/pyae002","url":null,"abstract":"<p><strong>Background: </strong>Cannabis use is a risk factor of psychiatric illness, such as bipolar disorder type-I (BDI). Indeed, cannabis use strongly influences the onset and clinical course of BDI, although the biological mechanisms underlying this interaction remain unknown. Therefore, we have reviewed the biological mechanisms affected by cannabis use that may trigger BD.</p><p><strong>Methods: </strong>A systematic review was carried out of articles in which gene expression was studied in cannabis users or human-derived cells exposed to tetrahydrocannabinol (THC) or cannabidiol (CBD). A second systematic review was then performed to identify articles in which gene expression was studied in BDI samples, highlighting those that described alterations to the same molecular and cellular mechanisms affected by cannabis/THC/CBD.</p><p><strong>Results: </strong>The initial search identified 82 studies on cannabis and 962 on BDI. After removing duplicates and applying the inclusion/exclusion criteria, 9 studies into cannabis and 228 on BDI were retained. The molecular and cellular mechanisms altered by cannabis use or THC/CBD exposure were then identified, including neural development and function, cytoskeletal function, cell adhesion, mitochondrial biology, inflammatory related pathways, lipid metabolism, the endocannabinoid system, the hypocretin/orexin system, and apoptosis. Alterations to those activities were also described in 19 of 228 focused on BDI.</p><p><strong>Conclusions: </strong>The biological mechanisms described in this study may be good candidates to the search for diagnostic biomarkers and therapeutic targets for BDI. Because cannabis use can trigger the onset of BD, further studies would be of interest to determine whether they are involved in the early development of the disorder, prompting early treatment.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10863486/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139086852","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}
引用次数: 0
Evenamide: A Potential Pharmacotherapeutic Alternative for Treatment-Resistant Schizophrenia. 偶氮酰胺:治疗耐药性精神分裂症的潜在药物疗法替代品。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyae005
Raghunath Singh, Margaret K Hahn, Yashika Bansal, Sri Mahavir Agarwal, Gary Remington
{"title":"Evenamide: A Potential Pharmacotherapeutic Alternative for Treatment-Resistant Schizophrenia.","authors":"Raghunath Singh, Margaret K Hahn, Yashika Bansal, Sri Mahavir Agarwal, Gary Remington","doi":"10.1093/ijnp/pyae005","DOIUrl":"10.1093/ijnp/pyae005","url":null,"abstract":"","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402802","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}
引用次数: 0
Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations. 帕潘立酮棕榈酸酯治疗成人精神分裂症患者的复发率:为期 6 个月的开放标签延长期研究结果与为期 1 个月和 3 个月制剂的实际数据对比。
IF 4.8 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-02-01 DOI: 10.1093/ijnp/pyad067
Ibrahim Turkoz, Mehmet Daskiran, Uzma Siddiqui, R Karl Knight, Karen L Johnston, Christoph U Correll
{"title":"Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations.","authors":"Ibrahim Turkoz, Mehmet Daskiran, Uzma Siddiqui, R Karl Knight, Karen L Johnston, Christoph U Correll","doi":"10.1093/ijnp/pyad067","DOIUrl":"10.1093/ijnp/pyad067","url":null,"abstract":"<p><strong>Background: </strong>The 3 paliperidone palmitate (PP) long-acting injectable antipsychotic formulations, PP 1-month (PP1M), PP 3-month (PP3M), and PP 6-month (PP6M), have shown to reduce the risk of relapse in schizophrenia. The current phase-4 study constructed external comparator arms (ECAs) using real-world data for PP3M and PP1M and compared relapse prevention rates with PP6M from an open-label extension (OLE) study in adult patients with schizophrenia.</p><p><strong>Methods: </strong>PP6M data were derived from a single-arm, 24-month, OLE study (NCT04072575), which included patients with schizophrenia who completed a 12-month randomized, double-blind, noninferiority, phase-3 study (NCT03345342) without relapse. Patients in the PP3M and PP1M ECAs were identified from the IBM® MarketScan® Multistate Medicaid Database based on similar eligibility criteria as the PP6M cohort.</p><p><strong>Results: </strong>A total of 178 patients were included in each cohort following propensity score matching. Most patients were men (>70%; mean age: 39-41 years). Time to relapse (primary analysis based on Kaplan-Meier estimates) was significantly delayed in the PP6M cohort (P < .001, log-rank test). The relapse rate was lower in the PP6M cohort (3.9%) vs PP3M (20.2%) and PP1M (29.8%) cohorts. Risk of relapse decreased significantly (P < .001) by 82% for PP6M vs PP3M (HR = 0.18 [95% CI = 0.08 to 0.40]), 89% for PP6M vs PP1M (HR = 0.11 [0.05 to 0.25]), and 35% for PP3M vs PP1M (HR = 0.65 [0.42 to 0.99]; P = .043). Sensitivity analysis confirmed findings from the primary analysis. Although the ECAs were matched to mimic the characteristics of the PP6M cohort, heterogeneity between the groups could exist due to factors including prior study participation, unmeasured confounders, variations in data capture and quality, and completeness of clinical information.</p><p><strong>Conclusions: </strong>In a clinical trial setting, PP6M significantly delayed time to relapse and demonstrated lower relapse rates compared with PP3M and PP1M treatments in real-world settings among adult patients with schizophrenia.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04072575; EudraCT number: 2018-004532-30.</p>","PeriodicalId":14134,"journal":{"name":"International Journal of Neuropsychopharmacology","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10873782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650752","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}
引用次数: 0
Ketamine or ECT? What Have We Learned From the KetECT and ELEKT-D Trials? 氯胺酮还是电痉挛疗法?我们从 KetECT 和 ELEKT-D 试验中学到了什么?
IF 4.5 2区 医学
International Journal of Neuropsychopharmacology Pub Date : 2024-01-01 DOI: 10.1093/ijnp/pyad065
Joakim Ekstrand, Akihiro Takamiya, Axel Nordenskjold, George Kirov, Pascal Sienaert, Charles H Kellner, Pouya Movahed Rad
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