Clinical Trials Of Antidepressants

Author : Martin M. Katz
Publisher : Springer
Page : 66 pages
File Size : 55,7 Mb
Release : 2016-02-08
Category : Psychology
ISBN : 9783319264646

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Clinical Trials of Antidepressants by Martin M. Katz Pdf

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.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 46,8 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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 : Michael P. Hengartner
Publisher : Springer Nature
Page : 355 pages
File Size : 47,8 Mb
Release : 2021-12-09
Category : Psychology
ISBN : 9783030825874

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Evidence-biased Antidepressant Prescription by Michael P. Hengartner Pdf

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.

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 724 pages
File Size : 45,8 Mb
Release : 2004
Category : Medical
ISBN : UVA:X005105317

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

Author : Peter D. Kramer
Publisher : Macmillan + ORM
Page : 322 pages
File Size : 48,7 Mb
Release : 2016-06-07
Category : Psychology
ISBN : 9780374708962

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Ordinarily Well by Peter D. Kramer Pdf

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.

Author : Irving Kirsch
Publisher : Random House
Page : 244 pages
File Size : 49,8 Mb
Release : 2009-10-13
Category : Business & Economics
ISBN : 9781409086352

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The Emperor's New Drugs by Irving Kirsch Pdf

Everyone knows that antidepressant drugs are miracles of modern medicine. Professor Irving Kirsch knew this as well as anyone. But, as he discovered during his research, there is a problem with what everyone knows about antidepressant drugs. It isn't true. How did antidepressant drugs gain their reputation as a magic bullet for depression? And why has it taken so long for the story to become public? Answering these questions takes us to the point where the lines between clinical research and marketing disappear altogether. Using the Freedom of Information Act, Kirsch accessed clinical trials that were withheld, by drug companies, from the public and from the doctors who prescribe antidepressants. What he found, and what he documents here, promises to bring revolutionary change to the way our society perceives, and consumes, antidepressants. The Emperor's New Drugs exposes what we have failed to see before: depression is not caused by a chemical imbalance in the brain; antidepressants are significantly more dangerous than other forms of treatment and are only marginally more effective than placebos; and, there are other ways to combat depression, treatments that don't only include the empty promise of the antidepressant prescription. This is not a book about alternative medicine and its outlandish claims. This is a book about fantasy and wishful thinking in the heart of clinical medicine, about the seductions of myth, and the final stubbornness of facts.

Author : Seymour Fisher,Roger P. Greenberg
Publisher : Routledge
Page : 619 pages
File Size : 52,5 Mb
Release : 2013-05-13
Category : Psychology
ISBN : 9781134738298

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The Limits of Biological Treatments for Psychological Distress by Seymour Fisher,Roger P. Greenberg Pdf

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.

Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher : Unknown
Page : 24 pages
File Size : 42,5 Mb
Release : 1977
Category : Antidepressants
ISBN : MINN:31951003051193H

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

Author : Jerry J. Buccafusco
Publisher : CRC Press
Page : 341 pages
File Size : 45,6 Mb
Release : 2000-08-29
Category : Medical
ISBN : 9781420041811

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Methods of Behavior Analysis in Neuroscience by Jerry J. Buccafusco Pdf

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

Author : Siegfried Kasper,Stuart A. Montgomery
Publisher : John Wiley & Sons
Page : 229 pages
File Size : 40,9 Mb
Release : 2013-04-15
Category : Medical
ISBN : 9781119952909

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Treatment-Resistant Depression by Siegfried Kasper,Stuart A. Montgomery Pdf

Treatment-resistant Depress Successful management of patients with treatment-resistant depression requires a thorough understanding of the biological basis for both the depression and its failure to respond to standard treatments. This book clearly and succinctly summarizes the latest scientific research and its applications in clinical practice. A first step is a clear definition of what constitutes treatment-resistant depression so that clinical trials and other studies are using common criteria, enabling comparison and meta-analysis of their outcomes. The opening chapter reviews definitions and predictors of treatment-resistant depression originating from different fields and discusses their usefulness in clinical practice and clinical research. The next chapter proposes a new definition, adapting terminology from medicine. Biological classification requires identification of genetic risk factors and gene variants have been identified as accounting for 50% of the variance in the clinical outcomes of antidepressant treatments. Chapter 3 describes several genes already associated with treatment-resistant depression and, while further work is needed to translate findings into clinical recommendations, suggests that genetic prediction of treatment resistance could become a widespread clinical reality within a few years. Most patients with treatment-resistant depression will be treated pharmacologically, so three chapters review the latest evidence for pharmacological best practice in switching strategies for antidepressants, the role of antipsychotics and augmentation strategies to complement lithium. There are two major alternatives to pharmacotherapy: neuromodulation and psychotherapy. The brain intervention chapter summarizes clinical research and experience with electroconvulsive therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation and magnetic seizure therapy. The final chapter reviews the literature pertaining to the effectiveness of various forms of psychotherapy in patients who have not responded to antidepressant pharmacotherapy, explaining that patients who have not responded to one or two trials of antidepressant medication have a 30%-50% chance of responding to a focused psychotherapy. It proposes indications for psychotherapy in treatment-resistant depression and summarizes general therapeutic principles. Essential reading for all psychiatrists managing patients with this distressing disorder.

Author : Bart Sheehan,Salman Karim,Alistair Burns
Publisher : OUP Oxford
Page : 0 pages
File Size : 51,8 Mb
Release : 2009-01-29
Category : Medical
ISBN : 0199216525

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Old Age Psychiatry by Bart Sheehan,Salman Karim,Alistair Burns Pdf

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.

Author : Anonim
Publisher : Academic Press
Page : 288 pages
File Size : 44,6 Mb
Release : 2019-07-13
Category : Medical
ISBN : 9780128173176

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Drug-Induced Liver Injury by Anonim Pdf

Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series

Author : Irving Kirsch
Publisher : ReadHowYouWant.com
Page : 358 pages
File Size : 48,8 Mb
Release : 2010-10-19
Category : Health & Fitness
ISBN : 9781458716767

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The Emperor's New Drugs by Irving Kirsch Pdf

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. His research has demonstrated that what everyone knew about antidepressants was wrong. Instead of treating depression with drugs, we've been treating it with suggestion.

Author : Matthew Macaluso,Sheldon H. Preskorn
Publisher : Springer
Page : 442 pages
File Size : 52,8 Mb
Release : 2019-05-31
Category : Medical
ISBN : 9783030109493

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Antidepressants by Matthew Macaluso,Sheldon H. Preskorn Pdf

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.

Author : Seymour Fisher,Roger P. Greenberg
Publisher : John Wiley & Sons
Page : 424 pages
File Size : 55,7 Mb
Release : 1997-10-07
Category : Medical
ISBN : UOM:39015041324297

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From Placebo to Panacea by Seymour Fisher,Roger P. Greenberg Pdf

From Placebo to Panacea systematically examines clinical research on the outcomes of common drug therapies for depression, psychosis, attention deficit, anxiety, and obsessive-compulsive disorder.