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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.
This book integrates the current state of knowledge on the association of neurochemical and psychological factors underlying the concept of depression or on the process and nature of the drug-induced changes that lead to recovery. Highlighting the results of two major multisite collaborative studies of the psychobiology of depression, the author demonstrates how more refined clinical methods uncover the initial behavioral actions of the drugs and chart the time course of their actions. The results disconfirm earlier textbook reported findings that these actions are delayed for several weeks beyond the almost immediate neurochemical effects. The "multivantaged" method makes possible distinguishing the clinical actions of different classes of antidepressant drugs.
THE SERIES The 10 volumes in this series record a fifty year history of neuropsychopharmacology related by 213 pioneer clinical, academic, industrial and basic scientists in videotaped interviews, conducted by 66 colleagues between 1994 and 2008. These volumes include a preface by the series editor placing its contents in an historical context and linking each volume to the next. Each volume is dedicated to a former President of the ACNP and edited by a distinguished historian or Fellow of the College who provides an introduction to its themes and a biography of each scientist's career. The series provides insights into a half century of discovery and innovation with its rewards and disappointments, progress and setbacks, including future expectations and hopes for the field as a whole and the ACNP as an organization. IN THIS VOLUME
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