Transforming Clinical Research in the United States

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Author :
Publisher : National Academies Press
ISBN 13 : 0309163358
Total Pages : 151 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Evidence-biased Antidepressant Prescription

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Author :
Publisher : Springer Nature
ISBN 13 : 3030825876
Total Pages : 355 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Evidence-biased Antidepressant Prescription by : Michael P. Hengartner

Download or read book Evidence-biased Antidepressant Prescription written by Michael P. Hengartner and published by Springer Nature. This book was released on 2021-12-09 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the over-prescribing of antidepressants in people with mostly mild and subthreshold depression. It outlines the steep increase in antidepressant prescription and critically examines the current scientific evidence on the efficacy and safety of antidepressants in depression. The book is not only concerned with the conflicting views as to whether antidepressants are useful or ineffective in various forms of depression, but also aims at detailing how flaws in the conduct and reporting of antidepressant trials have led to an overestimation of benefits and underestimation of harms. The transformation of the diagnostic concept of depression from a rare but serious disorder to an over-inclusive, highly prevalent but predominantly mild and self-limiting disorder is central to the books argument. It maintains that biological reductionism in psychiatry and pharmaceutical marketing reframed depression as a brain disorder, corroborating the overemphasis on drug treatment in both research and practice. Finally, the author goes on to explore how pharmaceutical companies have distorted the scientific literature on the efficacy and safety of antidepressants and how patient advocacy groups, leading academics, and medical organisations with pervasive financial ties to the industry helped to promote systematically biased benefit-harm evaluations, affecting public attitudes towards antidepressants as well as medical education, training, and practice.

Late-Life Depression

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Author :
Publisher : Oxford University Press
ISBN 13 : 0195152743
Total Pages : 417 pages
Book Rating : 4.1/5 (951 download)

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Book Synopsis Late-Life Depression by : Steven P. Roose

Download or read book Late-Life Depression written by Steven P. Roose and published by Oxford University Press. This book was released on 2004-07-15 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: We live in an aging world. Illnesses that are prevalent and cause significant morbidity and mortality in older people will consume an increasing share of health care resources. One such illness is depression. This illness has a particularly devastating impact in the elderly because it is often undiagnosed or inadequately treated. Depression not only has a profound impact on quality of life but it is associated with an increased risk of mortality from suicide and vascular disease. In fact for every medical illness studied, e.g. heart disease, diabetes, cancer, individuals who are depressed have a worse prognosis. Research has illuminated the physiological and behavioral effects of depression that accounts for these poor outcomes. The deleterious relationship between depression and other illnesses has changed the concept of late-life depression from a "psychiatric disorder" that is diagnosed and treated by a psychiatrist to a common and serious disorder that is the responsibility of all physicians who care for patients over the age of 60.This is the first volume devoted to the epidemiology, phenomenology, psychobiology, treatment and consequences of late-life depression. Although much has been written about depressive disorders, the focus has been primarily on the illness as experienced in younger adults. The effects of aging on the brain, the physiological and behavioral consequences of recurrent depression, and the impact of other diseases common in the elderly, make late-life depression a distinct entity. There is a compelling need for a separate research program, specialized treatments, and a book dedicated to this disorder. This book will be invaluable to psychiatrists, gerontologists, clinical psychologists, social workers, students, trainees, and others who care for individuals over the age of sixty.

Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials

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Author :
Publisher :
ISBN 13 :
Total Pages : 724 pages
Book Rating : 4.X/5 (5 download)

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Book Synopsis Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations

Download or read book Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2004 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ordinarily Well

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Publisher : Macmillan + ORM
ISBN 13 : 0374708967
Total Pages : 322 pages
Book Rating : 4.3/5 (747 download)

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Book Synopsis Ordinarily Well by : Peter D. Kramer

Download or read book Ordinarily Well written by Peter D. Kramer and published by Macmillan + ORM. This book was released on 2016-06-07 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do antidepressants work, or are they glorified dummy pills? How can we tell? In Ordinarily Well, the celebrated psychiatrist and author Peter D. Kramer examines the growing controversy about the popular medications. A practicing doctor who trained as a psychotherapist and worked with pioneers in psychopharmacology, Kramer combines moving accounts of his patients’ dilemmas with an eye-opening history of drug research to cast antidepressants in a new light. Kramer homes in on the moment of clinical decision making: Prescribe or not? What evidence should doctors bring to bear? Using the wide range of reference that readers have come to expect in his books, he traces and critiques the growth of skepticism toward antidepressants. He examines industry-sponsored research, highlighting its shortcomings. He unpacks the “inside baseball” of psychiatry—statistics—and shows how findings can be skewed toward desired conclusions. Kramer never loses sight of patients. He writes with empathy about his clinical encounters over decades as he weighed treatments, analyzed trial results, and observed medications’ influence on his patients’ symptoms, behavior, careers, families, and quality of life. He updates his prior writing about the nature of depression as a destructive illness and the effect of antidepressants on traits like low self-worth. Crucially, he shows how antidepressants act in practice: less often as miracle cures than as useful, and welcome, tools for helping troubled people achieve an underrated goal—becoming ordinarily well.

Clinical Trials of Antidepressants

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Author :
Publisher : Springer
ISBN 13 : 3319264648
Total Pages : 71 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Clinical Trials of Antidepressants by : Martin M. Katz

Download or read book Clinical Trials of Antidepressants written by Martin M. Katz and published by Springer. This book was released on 2016-02-08 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: This brief guide takes current clinical trial protocols to task and replaces them with a contemporary framework for improving next-generation antidepressants and their underlying science. Innovative models are based on a nuanced, neurologically-informed understanding of drug mechanisms and the component cognitive, mood, and behavioral aspects of depression. The book reconceptualizes not only the clinical trial process but the clinical concept of depression itself as essential to bringing pharmaceutical research and development up to date, boosting efficiency and effectiveness, finding new molecules, and reducing waste. Case studies and a review of salient depression scales illustrate the potential benefits of such wide-scale change. Included in the coverage: Why now the need for a new clinical trials model for antidepressants? Aims and basic requirements of clinical trials: conventional and component-specific models. Methods for measuring the components and the profile of drug actions: the multivantaged approach. Achieving the ideal clinical trial: an example of the merged componential and established models. Prediction and shortening the clinical trial. The video clinical trial. Clinical Trials of Antidepressants will interest a varied audience, including clinical investigators, academic and pharmaceutical company scientists, clinical trial organizations, psychiatrists, outpatient physicians, psychotherapists, clinical psychologists, psychology graduate students, medical students, and government agencies such as the FDA.

The Emperor's New Drugs

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Author :
Publisher : Basic Books
ISBN 13 : 0465021042
Total Pages : 242 pages
Book Rating : 4.4/5 (65 download)

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Book Synopsis The Emperor's New Drugs by : Irving Kirsch

Download or read book The Emperor's New Drugs written by Irving Kirsch and published by Basic Books. This book was released on 2010-01-26 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do antidepressants work? Of course -- everyone knows it. Like his colleagues, Irving Kirsch, a researcher and clinical psychologist, for years referred patients to psychiatrists to have their depression treated with drugs before deciding to investigate for himself just how effective the drugs actually were. Over the course of the past fifteen years, however, Kirsch's research -- a thorough analysis of decades of Food and Drug Administration data -- has demonstrated that what everyone knew about antidepressants was wrong. Instead of treating depression with drugs, we've been treating it with suggestion. The Emperor's New Drugs makes an overwhelming case that what had seemed a cornerstone of psychiatric treatment is little more than a faulty consensus. But Kirsch does more than just criticize: he offers a path society can follow so that we stop popping pills and start proper treatment for depression.

The Antidepressant Era

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Author :
Publisher : Harvard University Press
ISBN 13 : 9780674039582
Total Pages : 338 pages
Book Rating : 4.0/5 (395 download)

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Book Synopsis The Antidepressant Era by : David Healy

Download or read book The Antidepressant Era written by David Healy and published by Harvard University Press. This book was released on 1997 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this work Healy chronicles the history of psychopharmacology, from the discovery of chlorpromazine in 1951, to current battles over whether powerful chemical compounds should replace psychotherapy. The marketing of antidepressants is included.

Methods of Behavior Analysis in Neuroscience

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Publisher : CRC Press
ISBN 13 : 1420041819
Total Pages : 341 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Methods of Behavior Analysis in Neuroscience by : Jerry J. Buccafusco

Download or read book Methods of Behavior Analysis in Neuroscience written by Jerry J. Buccafusco and published by CRC Press. This book was released on 2000-08-29 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using the most well-studied behavioral analyses of animal subjects to promote a better understanding of the effects of disease and the effects of new therapeutic treatments on human cognition, Methods of Behavior Analysis in Neuroscience provides a reference manual for molecular and cellular research scientists in both academia and the pharmaceutic

Old Age Psychiatry

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Publisher : OUP Oxford
ISBN 13 : 9780199216529
Total Pages : 0 pages
Book Rating : 4.2/5 (165 download)

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Book Synopsis Old Age Psychiatry by : Bart Sheehan

Download or read book Old Age Psychiatry written by Bart Sheehan and published by OUP Oxford. This book was released on 2009-01-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Psychiatric disorders like dementia and depression are very common among older people. Written by experts in clinical practice, this handbook provides an easy to use and comprehensive account of what is known about these conditions, how clinicians can respond to given situations, and how services can be best organised.

Antidepressants

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Author :
Publisher : Springer
ISBN 13 : 3030109496
Total Pages : 442 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis Antidepressants by : Matthew Macaluso

Download or read book Antidepressants written by Matthew Macaluso and published by Springer. This book was released on 2019-05-31 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume reviews the known neurobiology of depression and combines classic data on antidepressant treatments with modern theory on the physiology of depression. It also discusses novel mechanism of action drugs.

The Limits of Biological Treatments for Psychological Distress

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Author :
Publisher : Routledge
ISBN 13 : 1134738293
Total Pages : 619 pages
Book Rating : 4.1/5 (347 download)

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Book Synopsis The Limits of Biological Treatments for Psychological Distress by : Seymour Fisher

Download or read book The Limits of Biological Treatments for Psychological Distress written by Seymour Fisher and published by Routledge. This book was released on 2013-05-13 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: Broadly scanning the biologically oriented treatments for psychological disorders in 20th century psychiatry, the authors raise serious questions about the efficacy of the somatic treatments for psychological distress and challenge the widespread preference for biologically based treatments as the treatments of choice. For graduate and undergraduate courses in clinical, social, and health psychology, behavioral medicine, psychotherapy and psychoanalysis. psychopharmacology, psychiatry, and clinical social work.

Guidelines for the Clinical Evaluation of Antidepressant Drugs

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Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Guidelines for the Clinical Evaluation of Antidepressant Drugs by : United States. Food and Drug Administration. Bureau of Drugs

Download or read book Guidelines for the Clinical Evaluation of Antidepressant Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Evidence-Based Guide to Antidepressant Medications

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Author :
Publisher : American Psychiatric Pub
ISBN 13 : 1585629804
Total Pages : 426 pages
Book Rating : 4.5/5 (856 download)

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Book Synopsis The Evidence-Based Guide to Antidepressant Medications by : Anthony J. Rothschild

Download or read book The Evidence-Based Guide to Antidepressant Medications written by Anthony J. Rothschild and published by American Psychiatric Pub. This book was released on 2012-09-24 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second book in the Evidence-Based Guides series, The Evidence-Based Guide to Antidepressant Medications, provides a clear reference to the current knowledge and evidence base for the use of antidepressants among a variety of patients across a wide range of disorders. Chapters within this guide are authored by experts in their respective areas of practice, and synthesize a large amount of medical literature into a comprehensive, yet understandable, concise, reader-friendly guide. Each chapter covers both the FDA-approved and off-label use of antidepressant medications and the evidence base for their use. Each chapter also features useful tables pertaining to specific topics, such as summaries of uses and efficacy, and important clinical pearls of wisdom in the Key Clinical Concepts. Topics covered in chapters within this text include: Use of selective serotonin reuptake inhibitors, MAOIs, and tricyclic antidepressants in major depressive disorder, bipolar depression, psychotic depression, and treatment-resistant depression. Acute management of anxiety disorders, obsessive-compulsive disorder, and specific phobias through antidepressant use. Use of antidepressant medication in medically ill patients, such as those with cardiovascular, pulmonary, gastrointestinal, renal, and endocrine diseases, as well as cancer, chronic pain, HIV, burns and hospital-based trauma. Developmental considerations necessary to keep in mind when prescribing antidepressants to children and adolescents, along with an outline of controlled studies and their special attention to safety. Medication management in geriatric patients, including antidepressant use among depressed elderly patients with dementia, stroke, or Parkinson's disease. Risks and benefits of prescribing antidepressants during pregnancy and lactation. Together, the authors have synthesized a large amount of medical literature into a comprehensive, yet understandable, concise, reader-friendly guide. The Evidence-Based Guide to Antidepressant Medications is a must-have reference for psychiatrists and other practicing clinicians, residents in training, psychiatric nurses, social workers and researchers.

Successful Drug Discovery, Volume 1

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Publisher : John Wiley & Sons
ISBN 13 : 3527336850
Total Pages : 258 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Successful Drug Discovery, Volume 1 by : János Fischer

Download or read book Successful Drug Discovery, Volume 1 written by János Fischer and published by John Wiley & Sons. This book was released on 2015-05-04 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first volume of the book series "Successful Drug Discovery" is focusing on new drug discoveries during the last decade, from established drugs to recently introduced drugs of all kinds: small-molecule-, peptide-, and protein-based drugs. The role of serendipity is analyzed in some very successful drugs where the research targets of the lead molecule and the drug are different. Phenotypic and target-based drug discovery approaches are discussed from the viewpoint of pioneer drugs and analogues. This volume gives an excellent overview of insulin analogues including a discussion of the properties of rapid-acting and long-acting formulations of this important hormone. The major part of the book is devoted to case histories of new drug discoveries described by their key inventors. Eight case histories range across many therapeutic fields. The goal of this book series is to help the participants of the drug research community with a reference book series and to support teaching in medicinal chemistry with case histories and review articles of new drugs.

Antidepressants

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Author :
Publisher : BoD – Books on Demand
ISBN 13 : 1789852668
Total Pages : 126 pages
Book Rating : 4.7/5 (898 download)

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Book Synopsis Antidepressants by : Olivier Berend

Download or read book Antidepressants written by Olivier Berend and published by BoD – Books on Demand. This book was released on 2019-11-20 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: Major depression is a severe and prevalent brain disorder with a high disability burden, hence the push for effective treatments. Antidepressants have been around since the 1950s, and although current medications are much more effective than early ones, there is still much room for improvement. "Real" antidepressants, defined as those that "repair" or "improve" the depression-causing mechanism in the brains of depressed patients, have yet to be identified. This book presents current research on depression and antidepressants, including use of antidepressants in alcohol use disorders and pregnancy, treatment-resistant depression, and development of potential new medications.

Ketamine for Treatment-Resistant Depression

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Author :
Publisher : Springer
ISBN 13 : 3319429256
Total Pages : 167 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Ketamine for Treatment-Resistant Depression by : Sanjay J. Mathew

Download or read book Ketamine for Treatment-Resistant Depression written by Sanjay J. Mathew and published by Springer. This book was released on 2016-11-25 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together an international group of clinicians and researchers from a broad swath of inter-related disciplines to offer the most up-to-date information about clinical and preclinical research into ketamine and second-generation “ketamine-like” fast-acting antidepressants. Currently available antidepressant medications act through monoaminergic systems, are ineffective for many individuals suffering from depression, and are associated with a delayed onset of peak efficacy of several months. The unexpected emergence of ketamine, an anesthetic N-methyl-D-aspartate (NMDA) receptor antagonist, as a rapid-acting antidepressant has reinvigorated CNS drug discovery research and catalyzed investigation in patient populations historically ignored in antidepressant drug development programs, particularly treatment-resistant patients and those with suicidality. Recent industry and academic research efforts have coalesced to explore NMDA receptor and glutamatergic molecular targets that lack ketamine’s psychotomimetic side effects and abuse liability but retain its rapid onset of efficacy. However, many fundamental questions remain regarding the neurobiological mechanisms underlying ketamine’s rapid antidepressant effects and the puzzling persistence of benefits observed in some patients following a single dose. This book examines how insights from these studies are forging new conceptual models of the neurobiology of stress-related affective, anxiety, and addictive disorders and the nature of treatment resistance. It also discusses how ketamine’s rapid antidepressant effects provide a scientific platform to facilitate innovation in clinical trial designs pertaining to patient selection, choice of control group, outcome measures, and dose-optimization. This book brings together data and insights from this rapidly expanding and extraordinarily promising field of study. Readers will be able to extract integrated themes and useful insights from the material contained in these diverse chapters and appreciate the paradigm-shifting contributions of ketamine to modern psychiatry and clinical neuroscience research.