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Modafinil Versus Amphetamine-Dextroamphetamine For Idiopathic Hypersomnia and Narcolepsy Type 2: A Randomized, Blinded, Non-inferiority Trial. 莫达非尼与安非他明-去甲安非他明治疗特发性失眠症和 2 型嗜睡症:随机、盲法、非劣效试验。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-11-01 Epub Date: 2024-09-21 DOI: 10.1007/s40263-024-01122-y
Lynn Marie Trotti, Tyler Blake, Romy Hoque, David B Rye, Surina Sharma, Donald L Bliwise
{"title":"Modafinil Versus Amphetamine-Dextroamphetamine For Idiopathic Hypersomnia and Narcolepsy Type 2: A Randomized, Blinded, Non-inferiority Trial.","authors":"Lynn Marie Trotti, Tyler Blake, Romy Hoque, David B Rye, Surina Sharma, Donald L Bliwise","doi":"10.1007/s40263-024-01122-y","DOIUrl":"10.1007/s40263-024-01122-y","url":null,"abstract":"<p><strong>Background and objective: </strong>Although there are several treatments for narcolepsy type 2 and idiopathic hypersomnia, studies that assess amphetamines, symptoms beyond sleepiness, and comparative effectiveness are needed. We performed a randomized, fully blinded, noninferiority trial of modafinil versus amphetamine-dextroamphetamine in these disorders.</p><p><strong>Methods: </strong>Forty-four adults were randomized to modafinil or amphetamine-dextroamphetamine, individually titrated to a maximum of modafinil 200 mg twice daily or amphetamine-dextroamphetamine 20 mg twice daily, for 12 weeks. Primary outcome was change in Epworth from baseline to week 12, with a noninferiority threshold of 2 points. Secondary outcomes were (1) patient global impression of change measures of disease severity, sleepiness, sleep inertia, and cognition; (2) change from baseline in Hypersomnia Severity Index; and (3) change from baseline in Sleep Inertia Questionnaire. Adverse events were compared between groups.</p><p><strong>Results: </strong>Epworth improved 5.0 [± standard deviation (SD) 2.7] points with modafinil and 4.4 (± SD 4.7) with amphetamine-dextroamphetamine; noninferiority of amphetamine-dextroamphetamine was not demonstrated (P = 0.11). Noninferiority of amphetamine-dextroamphetamine was demonstrated for change scores of severity, sleepiness, sleep inertia, Hypersomnia Severity Index, and Sleep Inertia Questionnaire. Dropouts due to adverse events were 31.8% for modafinil (including two severe events) and 9.1% for amphetamine-dextroamphetamine, P = 0.13. Anxiety was more common with modafinil and appetite suppression with amphetamine-dextroamphetamine.</p><p><strong>Conclusion: </strong>Noninferiority of amphetamine-dextroamphetamine to modafinil was not demonstrated for the primary outcome. However, amphetamine-dextroamphetamine was noninferior on multiple secondary measures of disease severity and symptomatology. These data may inform shared decision-making regarding treatment for idiopathic hypersomnia and narcolepsy type 2.</p><p><strong>Registration: </strong>Clinicaltrials.gov Registration (NCT03772314) 12/10/18. .</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"909-920"},"PeriodicalIF":7.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281509","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
Ozanimod: A Review in Relapsing Forms of Multiple Sclerosis. 奥扎莫德复发性多发性硬化症综述
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-11-01 Epub Date: 2024-10-05 DOI: 10.1007/s40263-024-01116-w
Tina Nie, Yahiya Y Syed
{"title":"Ozanimod: A Review in Relapsing Forms of Multiple Sclerosis.","authors":"Tina Nie, Yahiya Y Syed","doi":"10.1007/s40263-024-01116-w","DOIUrl":"10.1007/s40263-024-01116-w","url":null,"abstract":"<p><p>Ozanimod (Zeposia<sup>®</sup>), an orally administered sphingosine 1-phosphate (S1P) receptor modulator (S1PRM) that is selective for the S1P<sub>1</sub> and S1P<sub>5</sub> receptor subtypes, is approved in the USA for relapsing forms of multiple sclerosis (RMS). In pivotal phase III clinical trials in patients with RMS, ozanimod significantly reduced annualised relapse rates and the number of new or enlarging T2 lesions and gadolinium-enhancing lesions, and was associated with reduced brain volume loss, compared with interferon (IFN)-β1a. However, there were no significant differences in 3- and 6-month disability progression between the groups. Ozanimod was generally well tolerated, with the most common adverse reactions including upper respiratory tract infection and hepatic transaminase elevation. Efficacy and tolerability were sustained over more than 6 years with continued treatment. S1PRM-related adverse events seen with ozanimod are generally manageable with screening and/or monitoring. Notably, ozanimod does not require first-dose cardiac monitoring in the USA. In conclusion, ozanimod is a valuable once-daily oral disease-modifying therapy that extends the available treatment options for patients with RMS.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"931-941"},"PeriodicalIF":7.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379197","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
An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. 一项评估维洛沙嗪缓释胶囊对注意力缺陷/多动障碍成人的长期安全性和疗效的开放标签延伸研究。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-11-01 Epub Date: 2024-10-07 DOI: 10.1007/s40263-024-01120-0
Ann Childress, Andrew J Cutler, Lenard A Adler, Nicholas Fry, Kobby Asubonteng, Zulane Maldonado-Cruz, Andrea Formella, Jonathan Rubin
{"title":"An Open-Label Extension Study Assessing the Long-Term Safety and Efficacy of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder.","authors":"Ann Childress, Andrew J Cutler, Lenard A Adler, Nicholas Fry, Kobby Asubonteng, Zulane Maldonado-Cruz, Andrea Formella, Jonathan Rubin","doi":"10.1007/s40263-024-01120-0","DOIUrl":"10.1007/s40263-024-01120-0","url":null,"abstract":"<p><strong>Background and objective: </strong>Viloxazine ER (extended-release capsules; Qelbree<sup>®</sup>) is a nonstimulant medication that has been approved by the United States Food and Drug Administration (FDA) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children (> 6 years old) and adults. This phase 3 open-label extension to a pivotal phase 3, double-blind trial evaluated the long-term safety and continued efficacy of viloxazine ER in adults with ADHD.</p><p><strong>Methods: </strong>This was a multicenter, flexible-dose, open-label extension to a phase III, double-blind, placebo-controlled trial (NCT04016779). Viloxazine ER was initiated at 200 mg/day and adjusted (between 200 and 600 mg/day) to achieve optimal efficacy and tolerability. Trial enrollment was halted temporarily (24 March 2020 to 23 July 2020) due to the coronavirus disease 2019 (COVID-19) pandemic. Participants completing double-blind treatment during that time were offered delayed enrollment upon trial requalification. Safety outcomes were the primary objectives. Secondary objectives were efficacy outcomes, including the ADHD Investigator Symptom Rating Scale (AISRS), and were assessed relative to double-blind baseline (or trial re-entry baseline for those whose enrollment was delayed by the COVID-19 pandemic).</p><p><strong>Results: </strong>Overall, 159 participants (133 immediate and 26 delayed rollover) received viloxazine ER, with a mean exposure of 265 ± 254.9 days. Adverse events (AEs) included (> 10% incidence) insomnia (13.8%), nausea (13.8%), headache (10.7%), and fatigue (10.1%). AEs led to discontinuation for 17.6% of participants [most commonly insomnia (2.5%), nausea (2.5%), and fatigue (1.9%)]. AISRS total score [baseline mean ± standard deviation (SD): 37.9 ± 6.3] improved by the first follow-up visit (-11.4 ± 9.5; week 2) with continued improvement at subsequent visits (last on-study visit: -18.2 ± 11.54). Similar patterns of improvement were seen for other measures of efficacy, including quality of life and executive function. Following initial dose optimization, most participants (73%) used viloxazine ER doses ≥ 400 mg/day, with 36% using doses of 600 mg/day.</p><p><strong>Conclusions: </strong>Long-term viloxazine ER use was well tolerated, with no new long-term safety findings. Improvements in ADHD symptoms and associated measures were sustained throughout trial participation. In total, 73% percent of adult participants in this long-term study used viloxazine ER doses of 400 mg or more during maintenance treatment.</p><p><strong>Clinical trial registration: </strong>Clinicaltrials.gov Identifier: NCT04143217.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"891-907"},"PeriodicalIF":7.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11486793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380212","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
Acknowledgement to Referees. 鸣谢裁判员。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-11-01 DOI: 10.1007/s40263-024-01129-5
{"title":"Acknowledgement to Referees.","authors":"","doi":"10.1007/s40263-024-01129-5","DOIUrl":"https://doi.org/10.1007/s40263-024-01129-5","url":null,"abstract":"","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562731","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
Effectiveness of Disease-Modifying Treatment on Spinal Cord Lesion Formation in Relapse-Onset Multiple Sclerosis: An MSBase Registry Study. 疾病调整治疗对复发型多发性硬化症脊髓病变形成的影响:MSBase 登记研究
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-11-01 Epub Date: 2024-09-06 DOI: 10.1007/s40263-024-01115-x
Daniel Kreiter, Tomas Kalincik, Raymond Hupperts, Francesco Patti, Daniele Spitaleri, Matteo Foschi, Andrea Surcinelli, Davide Maimone, Bassem Yamout, Samia J Khoury, Jeannette Lechner-Scott, Serkan Ozakbas, Oliver Gerlach
{"title":"Effectiveness of Disease-Modifying Treatment on Spinal Cord Lesion Formation in Relapse-Onset Multiple Sclerosis: An MSBase Registry Study.","authors":"Daniel Kreiter, Tomas Kalincik, Raymond Hupperts, Francesco Patti, Daniele Spitaleri, Matteo Foschi, Andrea Surcinelli, Davide Maimone, Bassem Yamout, Samia J Khoury, Jeannette Lechner-Scott, Serkan Ozakbas, Oliver Gerlach","doi":"10.1007/s40263-024-01115-x","DOIUrl":"10.1007/s40263-024-01115-x","url":null,"abstract":"<p><strong>Background: </strong>Spinal cord lesions in multiple sclerosis (MS) have considerable impact on disability. High-efficacy disease-modifying treatments (hDMTs) are associated with greater reduction of relapses and new brain lesions compared to low-efficacy treatments (lDMTs). Knowledge on the impact of DMTs on cord lesion formation is limited as these outcome measures were not included in MS treatment trials. This study aims to investigate whether hDMTs reduce the formation of cord lesions more effectively than lDMTs.</p><p><strong>Methods: </strong>Patients with relapse-onset MS, a cord magnetic resonance imaging (MRI) within 6 months before/after initiation of their first DMT and ≥1 cord MRI at follow-up (interval > 6 months) were extracted from the MSBase registry (ACTRN12605000455662). Patients treated with hDMTs ≥90% or lDMTs ≥90% of follow-up duration were considered the hDMT and lDMT groups, respectively. Matching was performed using propensity scores. Cox proportional hazards models were used to estimate the hazards of new cord lesions, brain lesions and relapses.</p><p><strong>Results: </strong>Ninety-four and 783 satisfied hDMT and lDMT group criteria, respectively. Seventy-seven hDMT patients were matched to 184 lDMT patients. In the hDMT group there was no evidence of reduction of new cord lesions (hazard ratio [HR] 0.99 [95% CI 0.51, 1.92], p = 0.97), while there were fewer new brain lesions (HR 0.22 [95% CI 0.10, 0.49], p < 0.001) and fewer relapses (HR 0.45 [95% CI 0.28, 0.72], p = 0.004).</p><p><strong>Conclusion: </strong>A potential discrepancy exists in the effect of hDMTs over lDMTs in preventing spinal cord lesions versus brain lesions and relapses. While hDMTs provided a significant reduction for the latter when compared to lDMTs, there was no significant reduction in new spinal cord lesions.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"921-930"},"PeriodicalIF":7.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11486785/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145333","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
The Role of GABA Receptors in Anesthesia and Sedation: An Updated Review. GABA 受体在麻醉和镇静中的作用:最新综述。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-10-27 DOI: 10.1007/s40263-024-01128-6
Annlin Bejoy Philip, Janette Brohan, Basavana Goudra
{"title":"The Role of GABA Receptors in Anesthesia and Sedation: An Updated Review.","authors":"Annlin Bejoy Philip, Janette Brohan, Basavana Goudra","doi":"10.1007/s40263-024-01128-6","DOIUrl":"https://doi.org/10.1007/s40263-024-01128-6","url":null,"abstract":"&lt;p&gt;&lt;p&gt;GABA (γ-aminobutyric acid) receptors are constituents of many inhibitory synapses within the central nervous system. They are formed by 5 subunits out of 19 various subunits: α1-6, β1-3, γ1-3, δ, ε, θ, π, and ρ1-3. Two main subtypes of GABA receptors have been identified, namely GABAA and GABAB. The GABAA receptor (GABAAR) is formed by a variety of combinations of five subunits, although both α and β subunits must be included to produce a GABA-gated ion channel. Other subunits are γ, δ, ε, π, and ϴ. GABAAR has many isoforms, that dictate, among other properties, their differing affinities and conductance. Drugs acting on GABAAR form the cornerstone of anesthesia and sedation practice. Some such GABAAR agonists used in anesthesia practice are propofol, etomidate, methohexital, thiopental, isoflurane, sevoflurane, and desflurane. Ketamine, nitrous oxide, and xenon are not GABAR agonists and instead inhibit glutamate receptors-mainly NMDA receptors. Inspite of its many drawbacks such as pain in injection, quick and uncontrolled conversion from sedation to general anesthesia and dose-related cardiovascular depression, propofol remains the most popular GABAR agonist employed by anesthesia providers. In addition, being formulated in a lipid emulsion, contamination and bacterial growth is possible. Literature is rife with newer propofol formulations, aiming to address many of these drawbacks, and with some degree of success. A nonemulsion propofol formulation has been developed with cyclodextrins, which form inclusion complexes with drugs having lipophilic properties while maintaining aqueous solubility. Inhalational anesthetics are also GABA agonists. The binding sites are primarily located within α&lt;sup&gt;+&lt;/sup&gt;/β&lt;sup&gt;-&lt;/sup&gt; and β&lt;sup&gt;+&lt;/sup&gt;/α&lt;sup&gt;-&lt;/sup&gt; subunit interfaces, with residues in the α&lt;sup&gt;+&lt;/sup&gt;/γ&lt;sup&gt;-&lt;/sup&gt; interface. Isoflurane and sevoflurane might have slightly different binding sites providing unexpected degree of selectivity. Methoxyflurane has made a comeback in Europe for rapid provision of analgesia in the emergency departments. Penthrox (Galen, UK) is the special device designed for its administration. With better understanding of pharmacology of GABAAR agonists, newer sedative agents have been developed, which utilize \"soft pharmacology,\" a term pertaining to agents that are rapidly metabolized into inactive metabolites after producing desired therapeutic effect(s). These newer \"soft\" GABAAR agonists have many properties of ideal sedative agents, as they can offer well-controlled, titratable activity and ultrashort action. Remimazolam, a modified midazolam and methoxycarbonyl-etomidate (MOC-etomidate), an ultrashort-acting etomidate analog are two such examples. Cyclopropyl methoxycarbonyl metomidate is another second-generation soft etomidate analog that has a greater potency and longer half-life than MOC-etomidate. Additionally, it might not cause adrenal axis suppression. Carboetomidate is another soft analog of etom","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2024-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496460","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
The Safety of Alcohol Pharmacotherapies in Pregnancy: A Scoping Review of Human and Animal Research. 妊娠期酒精药物治疗的安全性:人类和动物研究范围综述》。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-10-10 DOI: 10.1007/s40263-024-01126-8
Ebony Quintrell, Danielle J Russell, Sofa Rahmannia, Caitlin S Wyrwoll, Alexander Larcombe, Erin Kelty
{"title":"The Safety of Alcohol Pharmacotherapies in Pregnancy: A Scoping Review of Human and Animal Research.","authors":"Ebony Quintrell, Danielle J Russell, Sofa Rahmannia, Caitlin S Wyrwoll, Alexander Larcombe, Erin Kelty","doi":"10.1007/s40263-024-01126-8","DOIUrl":"https://doi.org/10.1007/s40263-024-01126-8","url":null,"abstract":"<p><strong>Background and objective: </strong>Alcohol pharmacotherapies pose unknown teratogenic risks in pregnancy and are therefore recommended to be avoided. This limits treatment options for pregnant individuals with alcohol use disorders (AUD). The information on the safety of these medications during pregnancy is uncertain, prompting a scoping review. The objective of this review was to investigate available information on the safety of alcohol pharmacotherapies in pregnancy.</p><p><strong>Methods: </strong>Studies published between January 1990 and July 2023 were identified through searches in BIOSIS, Embase, PsycINFO and MEDLINE databases, using terms related to pregnancy and alcohol pharmacotherapies. The alcohol pharmacotherapies investigated were naltrexone, acamprosate, disulfiram, nalmefene, baclofen, gabapentin and topiramate. Studies were screened by two independent reviewers. Covidence software facilitated the management, screening and extraction of studies.</p><p><strong>Results: </strong>A total of 105 studies were included in the review (naltrexone: 21, acamprosate: 4, disulfiram: 3, baclofen: 3, nalmefene: 0, topiramate: 55, gabapentin: 32) with some studies investigating multiple medications. Studies investigating naltrexone's safety in pregnancy focussed on opioid use disorders, with limited evidence regarding its safety in the context of AUD. Despite concerns about higher rates of some pregnancy complications, studies generally indicate naltrexone as a safer option compared with opioid agonists or alcohol during pregnancy. Acamprosate was not clearly associated with adverse effects of exposure in pregnancy, with two pre-clinical studies suggesting potential neuroprotective properties. Disulfiram has a high risk of congenital anomalies when used in pregnancy, believed to be due to its mechanism of action. Prenatal topiramate has also been associated with an increased risk of congenital anomalies, particularly oral clefts. There were mixed results concerning the safety of prenatal gabapentin and little to no literature investigating the safety of baclofen or nalmefene during pregnancy.</p><p><strong>Conclusions: </strong>There is insufficient research on the safety of alcohol pharmacotherapies in pregnancy. Despite this, given alcohol's teratogenic effects, naltrexone could be considered to help maintain abstinence in pregnant individuals with AUD, particularly when psychosocial treatments have failed.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399631","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
Current Perspectives on the Clinical Research and Medicalization of Psychedelic Drugs for Addiction Treatments: Safety, Efficacy, Limitations and Challenges. 关于迷幻药物用于成瘾治疗的临床研究和医学化的当前视角:安全性、有效性、局限性和挑战。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-10-01 Epub Date: 2024-07-20 DOI: 10.1007/s40263-024-01101-3
Anton Gomez-Escolar, Daniel Folch-Sanchez, Joanna Stefaniuk, Zoe Swithenbank, Andreia Nisa, Fleur Braddick, Nazish Idrees Chaudhary, Pim B van der Meer, Albert Batalla
{"title":"Current Perspectives on the Clinical Research and Medicalization of Psychedelic Drugs for Addiction Treatments: Safety, Efficacy, Limitations and Challenges.","authors":"Anton Gomez-Escolar, Daniel Folch-Sanchez, Joanna Stefaniuk, Zoe Swithenbank, Andreia Nisa, Fleur Braddick, Nazish Idrees Chaudhary, Pim B van der Meer, Albert Batalla","doi":"10.1007/s40263-024-01101-3","DOIUrl":"10.1007/s40263-024-01101-3","url":null,"abstract":"<p><p>Mental health disorders and substance use disorders (SUDs) in particular, contribute greatly to the global burden of disease. Psychedelics, including entactogens and dissociative substances, are currently being explored for the treatment of SUDs, yet with less empirical clinical evidence than for other mental health disorders, such as depression or post-traumatic stress disorder (PTSD). In this narrative review, we discuss the current clinical research evidence, therapeutic potential and safety of psilocybin, lysergic acid diethylamide (LSD), ketamine, 3,4-methylenedioxymethamphetamine (MDMA) and ibogaine, particularly in the context of the SUD treatment. Our aim was to provide a balanced overview of the current research and findings on potential benefits and harms of psychedelics in clinical settings for SUD treatment. We highlight the need for more clinical research in this particular treatment area and point out some limitations and challenges to be addressed in future research.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"771-789"},"PeriodicalIF":7.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733720","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
New and Emerging Drug and Gene Therapies for Friedreich Ataxia. 治疗弗里德里希共济失调的新兴药物和基因疗法。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-10-01 Epub Date: 2024-08-08 DOI: 10.1007/s40263-024-01113-z
Varlli Scott, Martin B Delatycki, Geneieve Tai, Louise A Corben
{"title":"New and Emerging Drug and Gene Therapies for Friedreich Ataxia.","authors":"Varlli Scott, Martin B Delatycki, Geneieve Tai, Louise A Corben","doi":"10.1007/s40263-024-01113-z","DOIUrl":"10.1007/s40263-024-01113-z","url":null,"abstract":"<p><p>The life shortening nature of Friedreich Ataxia (FRDA) demands the search for therapies that can delay, stop or reverse its relentless trajectory. This review provides a contemporary position of drug and gene therapies for FRDA currently in phase 1 clinical trials and beyond. Despite significant scientific advances in the specificity of both compounds and targets developed and investigated, challenges remain for the advancement of treatments in a limited recruitment population. Currently therapies focus on reducing oxidative stress and improving mitochondrial function, modulating frataxin controlled metabolic pathways and gene replacement and editing. Approval of omaveloxolone, the first treatment for individuals with FRDA aged 16 years and over, has created much excitement for both those living with FRDA and those that care for them. The process of approval of omaveloxolone by the US Food and Drug Administration highlighted the importance of sensitive outcome measures and the significant role of data from natural history studies.</p>","PeriodicalId":10508,"journal":{"name":"CNS drugs","volume":" ","pages":"791-805"},"PeriodicalIF":7.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901180","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
Assessment of Bone Mineral Density Over 1 Year in a Cross-Sectional Cohort of Migraine Patients Receiving Anti-CGRP Monoclonal Antibodies. 评估接受抗 CGRP 单克隆抗体治疗的偏头痛患者横断面队列一年内的骨矿物质密度。
IF 7.4 2区 医学
CNS drugs Pub Date : 2024-10-01 Epub Date: 2024-08-22 DOI: 10.1007/s40263-024-01104-0
Davide Para, Chiara Camponovo, Gianna Carla Riccitelli, Giulia Mallucci, Paolo Maino, Camilla Mondini Trissino da Lodi, Demurtas Saudina, Pierpaolo Trimboli, Claudio Gobbi, Chiara Zecca
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