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Clinical Trials Of Antidepressants

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Author by : Martin M. Katz
Languange Used : en
Release Date : 2016-02-08
Publisher by : Springer

ISBN : 9783319264646

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....

Publication And Disclosure Issues In Antidepressant Pediatric Clinical Trials

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Author by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Languange Used : en
Release Date : 2004
Publisher by :

ISBN : STANFORD:36105050377634

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Transforming Clinical Research In The United States

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Author by : Institute of Medicine
Languange Used : en
Release Date : 2010-10-22
Publisher by : National Academies Press

ISBN : 9780309163354

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....

Children Of The Cure

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Author by : Joanna Le Noury
Languange Used : en
Release Date : 2020-05-21
Publisher by :

ISBN : 177705656X

Children of the Cure tells the story of the only Medical Study that has two publications in the academic literature-telling precisely the opposite story-and how no one is bothered by this. Study 329 was a clinical study that began in 1994 giving a new antidepressant to teenagers. It has become the most famous clinical trial ever, leading to a fraud charge, a $3 billion fine, and a Black Box Warning. Despite now knowing that all trials of antidepressants done in children are negative, sales of these drugs to children and adolescents continue to increase dramatically. This book is written by three members of the team-David Healy, Joanna Le Noury and Julie Wood-who have been behind writing the study and creating the website that hosts a set of documents pharmaceutical companies never expected you would get to see....

Guidelines For The Clinical Evaluation Of Antidepressant Drugs

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Author by : United States. Food and Drug Administration. Bureau of Drugs
Languange Used : en
Release Date : 1977
Publisher by :

ISBN : UOM:39015003204818

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The Emperor S New Drugs

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Author by : Irving Kirsch
Languange Used : en
Release Date : 2010-10-19
Publisher by : ReadHowYouWant.com

ISBN : 9781458716767

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....

Evidence Biased Antidepressant Prescription

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Author by : Michael P. Hengartner
Languange Used : en
Release Date : 2021-12-09
Publisher by : Springer Nature

ISBN : 9783030825874

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....

Treatment Resistant Depression

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Author by : Siegfried Kasper
Languange Used : en
Release Date : 2013-04-15
Publisher by : John Wiley & Sons

ISBN : 9781119952909

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....

The Documentation Of Clinical Psychotropic Drug Trials

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Author by : National Institute of Mental Health (U.S.)
Languange Used : en
Release Date : 1973
Publisher by :

ISBN : OSU:32435026800847

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Ketamine For Treatment Resistant Depression

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Author by : Sanjay J. Mathew
Languange Used : en
Release Date : 2016-11-25
Publisher by : Springer

ISBN : 9783319429250

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....