Clinical Trial Design Challenges In Mood Disorders

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• Author : Mauricio Tohen,Charles Bowden,Andrew A. Nierenberg,John Geddes
• Publisher : Academic Press
• Release Date : 2015-01-24
• Total pages : 192
• ISBN : 9780124051768
• File Size : 45,6 Mb
• Total Download : 962
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Download Clinical Trial Design Challenges in Mood Disorders in PDF, Epub, and Kindle

Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

• Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
• Publisher : National Academies Press
• Release Date : 2016-12-07
• Total pages : 111
• ISBN : 9780309442558
• File Size : 31,7 Mb
• Total Download : 924
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Download Neuroscience Trials of the Future in PDF, Epub, and Kindle

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

• Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
• Publisher : National Academies Press
• Release Date : 2001-01-01
• Total pages : 222
• ISBN : 0309171148
• File Size : 23,6 Mb
• Total Download : 887
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Download Small Clinical Trials in PDF, Epub, and Kindle

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

• Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
• Publisher : National Academies Press
• Release Date : 2014-02-06
• Total pages : 118
• ISBN : 9780309292498
• File Size : 43,5 Mb
• Total Download : 731
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Download Improving and Accelerating Therapeutic Development for Nervous System Disorders in PDF, Epub, and Kindle

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

• Author : Lynda H. Powell,Kenneth E. Freedland,Peter G. Kaufmann
• Publisher : Springer Nature
• Release Date : 2021-10-13
• Total pages : 324
• ISBN : 9783030393304
• File Size : 30,9 Mb
• Total Download : 861
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Download Behavioral Clinical Trials for Chronic Diseases in PDF, Epub, and Kindle

This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

• Author : Aysegül Yildiz,Pedro Ruiz,Charles B. Nemeroff
• Publisher : Oxford University Press, USA
• Release Date : 2015
• Total pages : 710
• ISBN : 9780199300532
• File Size : 46,6 Mb
• Total Download : 719
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Download The Bipolar Book in PDF, Epub, and Kindle

The Bipolar Book covers not only clinical and pathophysiological matters, but also technical aspects of the evidence accumulation for treatment of bipolar disorder.

• Author : Charles B. Nemeroff, M.D., Ph.D.,Alan F. Schatzberg, M.D.,Natalie Rasgon, M.D., Ph.D.,Stephen M. Strakowski, M.D.
• Publisher : American Psychiatric Pub
• Release Date : 2022-06-16
• Total pages : 988
• ISBN : 9781615373314
• File Size : 25,6 Mb
• Total Download : 352
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Download The American Psychiatric Association Publishing Textbook of Mood Disorders, Second Edition in PDF, Epub, and Kindle

Preceded by: The American Psychiatric Publishing textbook of mood disorders / edited by Dan J. Stein, David J. Kupfer, Alan F. Schatzberg. 1st ed. c2006.

• Author : Antonio Cherubini,Roberto Bernabei,Luigi Ferrucci,Niccolò Marchionni,Stephanie Studenski,Bruno Vellas
• Publisher : John Wiley & Sons
• Release Date : 2016-01-13
• Total pages : 280
• ISBN : 9781118323472
• File Size : 16,9 Mb
• Total Download : 387
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Download Clinical Trials in Older Adults in PDF, Epub, and Kindle

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer

• Author : Arthur L. Caplan,Brendan Parent
• Publisher : Routledge
• Release Date : 2020-09-10
• Total pages : 482
• ISBN : 9781000151992
• File Size : 34,5 Mb
• Total Download : 591
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Download The Ethical Challenges of Emerging Medical Technologies in PDF, Epub, and Kindle

This collection of essays emphasizes society’s increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology’s strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare.

• Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
• Publisher : National Academies Press
• Release Date : 2010-10-22
• Total pages : 150
• ISBN : 0309163358
• File Size : 51,8 Mb
• Total Download : 419
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Download Transforming Clinical Research in the United States in PDF, Epub, and Kindle

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

• Author : S. Hossein Fatemi,Paula J. Clayton
• Publisher : Springer
• Release Date : 2016-03-17
• Total pages : 1064
• ISBN : 9781493925285
• File Size : 27,8 Mb
• Total Download : 967
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Download The Medical Basis of Psychiatry in PDF, Epub, and Kindle

Four years have passed since the last edition (3rd) of this book was published. In the intervening years, several reviews of this book have provided highly encouraging remarks about the value of this book in transmitting information on classification and treatment of psychiatric disorders to the audience. We are proposing to revise all chapters with an eye on accuracy and ease of use, and this is an especially timely endeavor with the upcoming publication of the Diagnostic and Statistical Manual V. All the appropriate new information on biology, etiology, diagnosis and treatment of psychiatric disorders will be added to the current proposed edition. It is our goal to recruit the same authors (if possible) who contributed to the previous edition. While all chapters will be updated (see TOC), those marked by asterisks will be the most likely to undergo more revision. Psychiatry has emerged as a burgeoning scientific field with major advances in etiology and treatment of several disorders. Just as there was excitement in the anatomic advances that took place a hundred years ago when Emil Kraepelin and his collaborators took on the enormous task of classification of psychiatric disorders based on rational scientific thinking, new advances in genetics, biochemistry, neuroanatomy and pharmacotherapy of mental disorders have brought us even closer to a better understanding of complex disorders like schizophrenia, bipolar disorder, depression and even autism. The major goal of the previous edition of this classic book was to update the busy clinician, psychiatric resident and medical student with the most up-to-date information on etiology, diagnosis and treatment of psychiatric disorders. This goal remains the focus of the fourth edition of this book. In this updated and expanded edition, the reader will be provided with the most contemporary information and literature supported by a close survey of the field. This new edition of this classic title, with its focus on biologic and medical aspects of psychiatry, will continue to be of significant help to all interested in the scientific practice of psychiatry.

• Author : Peter Ellis
• Publisher : Learning Matters
• Release Date : 2022-04-08
• Total pages : 200
• ISBN : 9781529786668
• File Size : 12,8 Mb
• Total Download : 470
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Download Understanding Research for Nursing Students in PDF, Epub, and Kindle

Get to grips with all aspects of research that you need to succeed in your nursing degree. Learn why research is so important to nursing, develop your knowledge of key methods and terminology and build your confidence in applying research principles to your nursing practice. Key features o Each chapter is mapped to the 2018 NMC standards, showing how research relates to the requirements of a registered nurse o Straightforward language and a step-by-step approach introduce you to key concepts and guide you through all aspects of the research process o Filled with activities and case studies to help you apply research principles and methods to your studies and practice

• Author : Martin B. Keller,William H. Coryell,Jean Endicott,Jack D. Maser,Pamela J. Schettler
• Publisher : American Psychiatric Pub
• Release Date : 2013-04-10
• Total pages : 236
• ISBN : 9781585629947
• File Size : 50,6 Mb
• Total Download : 807
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Download Clinical Guide to Depression and Bipolar Disorder in PDF, Epub, and Kindle

Conceived in the early 1970s to study the phenomenology, diagnosis, genetics, and clinical course of depression, the NIMH Collaborative Depression Study (CDS) has influenced research and practice since its inception. Clinical Guide to Depression and Bipolar Disorder: Findings From the Collaborative Depression Study summarizes key findings from the study and the related literature to provide comprehensive and up-to-date knowledge on the course and outcome of illness in mood disorders. Nowhere else can clinicians find such detailed longitudinal data, combined with astute clinical analysis of the current research. The volume offers: Historical background on how psychodynamic psychiatry was overtaken by psychobiological perspectives, and the challenges and controversies that gave rise to the CDS, providing the context necessary to understand the profession's development to the present day. A wealth of information on nosology, natural history, phenomenology, and treatment response in depressive and bipolar disorders. Detailed descriptions of the study methods employed, providing information and insights that will assist researchers in the longitudinal design of prospective cohort studies. Comprehensive review of outcomes in mood disorder, including delineation of the long-term course of bipolar I, bipolar II, and unipolar major depressive disorders, the implications of which will continue to be instrumental in the development of psychiatric nosology and indispensable to clinicians engaged in assessment and treatment. Critical information clinicians need in order to read the clinical signs in their patients and predict the "switch" from unipolar to bipolar disorder. A fascinating review of the evolution of diagnostic thinking about the role of anxiety in mood disorders, and the contributions of the CDS to the newly published DSM-5®. Each chapter is accompanied by a time-saving summary, as well as a section on clinical implications that translates the findings into practical points and key recommendations clinicians need to know to provide optimal care. Psychiatrists, clinical psychologists, residents, and fellows will turn to Clinical Guide to Depression and Bipolar Disorder: Findings From the Collaborative Depression Study to better understand the course and outcome of their patients' mood disorders and, ultimately, to improve their clinical skills.

• Author : Patrick P. Coll
• Publisher : Springer
• Release Date : 2019-03-29
• Total pages : 399
• ISBN : 9783030062002
• File Size : 50,9 Mb
• Total Download : 562
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Download Healthy Aging in PDF, Epub, and Kindle

This book weaves all of these factors together to engage in and promote medical, biomedical and psychosocial interventions, including lifestyle changes, for healthier aging outcomes. The text begins with an introduction to age-related changes that increase in disease and disability commonly associated with old age. Written by experts in healthy aging, the text approaches the principles of disease and disability prevention via specific health issues. Each chapter highlights the challenge of not just increasing life expectancy but also deceasing disease burden and disability in old age. The text then shifts into the whole-person implications for clinicians working with older patients, including the social and cultural considerations that are necessary for improved outcomes as Baby Boomers age and healthcare systems worldwide adjust. Healthy Aging is an important resource for those working with older patients, including geriatricians, family medicine physicians, nurses, gerontologists, students, public health administrators, and all other medical professionals.

• Author : Jacqueline Corcoran
• Publisher : Routledge
• Release Date : 2016-06-10
• Total pages : 366
• ISBN : 9781317811244
• File Size : 17,8 Mb
• Total Download : 228
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Download Living with Mental Disorder in PDF, Epub, and Kindle

This evidence-based text puts a human face on mental disorders, illuminating the lived experience of people with mental health difficulties and their caregivers. Systematically reviewing the qualitative research conducted on living with a mental disorder, this text coalesces a large body of knowledge and centers on those disorders that have sufficient qualitative research to synthesize, including attention-deficit/hyperactivity disorder, autism, intellectual disabilities, mood disorders, schizophrenia and dementia. Supported by numerous quotes, the text explores the perspective of those suffering with a mental disorder and their caregivers, discovering their experience of burden, their understanding of and the meaning they give to their disorder, the strengths and coping they have used to manage, as well as their interactions with the formal treatment system and the use of medication. This book will be of immense value to students, practitioners, and academics that support, study, and treat people in mental distress and their families.

• Author : Anka A. Vujanovic,Sudie E. Back
• Publisher : Routledge
• Release Date : 2019-04-23
• Total pages : 376
• ISBN : 9781315442624
• File Size : 24,7 Mb
• Total Download : 210
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Download Posttraumatic Stress and Substance Use Disorders in PDF, Epub, and Kindle

Posttraumatic Stress and Substance Use Disorders summarizes the state of the field from a biopsychosocial perspective, addressing key domains of interest to clinicians, students, instructors, and researchers. This book is a valuable resource and reference guide for multidisciplinary practitioners and scientists interested in the evidence-based assessment and treatment of posttraumatic stress and substance use disorders. Chapters written by leaders in the field cover the latest research on assessment, diagnosis, evidence-based treatments, future directions, and much more.

• Author : John B. Taylor,Judith Puckett
• Publisher : Lippincott Williams & Wilkins
• Release Date : 2019-03-21
• Total pages : 350
• ISBN : 9781975117948
• File Size : 16,6 Mb
• Total Download : 133
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Download Pocket Psychiatry in PDF, Epub, and Kindle

Pocket Psychiatry, a new addition to the Pocket Notebook series, is written by residents for residents. A resource for essential information, in a high-yield, easy-to-use format, designed to help students, trainees, and others navigate the initial psychiatric evaluation and management of the most commonly encountered psychiatric conditions. With an emphasis on evidence-based information, Pocket Psychiatry, provides a rare concise and accessible resource, for must-know information on hospital- and clinic-based psychiatric care — from history and physical exam to differential diagnosis testing to therapeutics — in the well known loose leaf pocket size format.

• Author : Richard S. E. Keefe,Abraham Reichenberg,Jeffrey Cummings
• Publisher : Oxford University Press
• Release Date : 2017-11-28
• Total pages : 449
• ISBN : 9780190214401
• File Size : 20,8 Mb
• Total Download : 417
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Download Cognitive Enhancement in CNS Disorders and Beyond in PDF, Epub, and Kindle

This text compiles a series of educational and thought-provoking chapters from the world's leading cognitive and clinical scientists to describe the latest research on cognitive impairments in a host of pathological conditions that affect CNS functioning, the available treatments for these impairments, and how new treatments are being tested. This volume advances the field toward the availability of cognitive enhancing drugs and devices that will benefit those who need them most and others who may believe that these techniques can help them to thrive

• Author : Jair Soares,Consuelo Walss-Bass,Paolo Brambilla
• Publisher : Academic Press
• Release Date : 2018-06-09
• Total pages : 288
• ISBN : 9780128125601
• File Size : 34,7 Mb
• Total Download : 463
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Download Bipolar Disorder Vulnerability in PDF, Epub, and Kindle

Bipolar Disorder Vulnerability: Perspectives from Pediatric and High-Risk Populations synthesizes our current understanding of high-risk and pediatric populations to aid readers in identifying markers of vulnerability for the development of bipolar disorder, with an ultimate goal of the development of drug targets and other therapies for early diagnosis and treatment. The book provides readers with an understanding of biological and environmental factors influencing disease manifestation that will aid them in defining discrete clinical stages and, importantly, establish an empirical basis for the application of novel therapeutics in a phase of illness during which specific treatments could more effectively alter disease course. Whereas most of the literature available on the pathophysiological mechanisms of bipolar disorder focuses on chronically ill adult individuals, this represents the only book that specifically examines pediatric and high-risk populations. An estimated 30 to 60 percent of adult bipolar disorder patients have their disease onset during childhood, with early-onset cases representing a particularly severe and genetically loaded form of the illness. Highlights diverse translational methodologies, including functional and structural neuroimaging, neuropsychological testing and integrated genomics Examines molecular trajectories in youth with bipolar disorder and unaffected youth at high risk for developing bipolar disorder Explores the interaction between genomic and environmental influences that shape behavior

• Author : Renato de Filippis,Mohammadreza Shalbafan,Samer El Hayek
• Publisher : Frontiers Media SA
• Release Date : 2023-05-09
• Total pages : 94
• ISBN : 9782832521014
• File Size : 49,7 Mb
• Total Download : 256
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Download Community Series in Mental Illness, Culture, and Society: Dealing with the COVID-19 Pandemic, Volume IV in PDF, Epub, and Kindle

PDF book entitled Community Series in Mental Illness, Culture, and Society: Dealing with the COVID-19 Pandemic, Volume IV written by Renato de Filippis,Mohammadreza Shalbafan,Samer El Hayek and published by Frontiers Media SA which was released on 2023-05-09 with total hardcover pages 94, the book become popular and critical acclaim.

• Author : Gustavo H. Vazquez,Carlos A. Zarate,Elisa Brietzke
• Publisher : Academic Press
• Release Date : 2020-09-16
• Total pages : 168
• ISBN : 9780128210345
• File Size : 9,7 Mb
• Total Download : 167
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Download Ketamine for Treatment-Resistant Depression in PDF, Epub, and Kindle

Ketamine for Treatment-Resistant Depression: Neurobiology and Applications provides a simple, evidence-based overview for neuropsychiatrists and translational researchers on this medication, its mechanisms of actions, eligibility of patients for treatment, and the preparation and implementation of ketamine clinics. Provides efficacy research on ketamine as a treatment for depression Identifies best practices for clinical use, both long-term and acute Discusses the molecular mechanisms and neurobiology of action