This brief guide takes current clinical trial protocols totask and replaces them with a contemporary framework for improvingnext-generation antidepressants and their underlying science. Innovative modelsare based on a nuanced, neurologically-informed understanding of drugmechanisms and the component cognitive, mood, and behavioral aspects ofdepression. The book reconceptualizes not only the clinical trial process butthe clinical concept of depression itself as essential to bringingpharmaceutical research and development up to date, boosting efficiency andeffectiveness, finding new molecules, and reducing waste. Case studies and areview of salient depression scales illustrate the potential benefits of suchwide-scale change.Included in the coverage:Whynow the need for a new clinical trials model for antidepressants? Aimsand basic requirements of clinical trials: conventional andcomponent-specific models.Methodsfor measuring the components and the profile of drug
actions: themultivantaged approach.Achievingthe ideal clinical trial: an example of the merged componential andestablished models.Predictionand shortening the clinical trial.Thevideo clinical trial. Clinical Trials ofAntidepressants will interest a varied audience, including clinicalinvestigators, academic and pharmaceutical company scientists, clinical trialorganizations, psychiatrists, outpatient physicians, psychotherapists, clinicalpsychologists, psychology graduate students, medical students, and governmentagencies such as the FDA.
Introduction.- Why Now the Need for a New Clinical Trial Model for Antidepressants .- Reconceptualizing Depression and the Componential-Specific Model of Clinical Trials.- Aims and Basic requirements of Clinical Trials: Conventional and Component-Specific Models.- Methods for Measuring the Components and Profile of Drug Actions: The Multivantaged Approach.- The Component-Specific Model Applied in a Clinical Trial: An Example.- Comparing the Component-Specific Model Directly with the Established Diagnosis-Specific Trial.- Prediction and Shortening the Clinical Trial: Further Advantages of the Component-Specific Model.- The Video Clinical Trial and the VIBES Method.- Conclusions.
Introduction.- Why Now the Need for a New Clinical Trial Model for Antidepressants?.- Reconceptualizing Depression and the Componential-Specific Model of Clinical Trials.- Aims and Basic requirements of Clinical Trials: Conventional and Component-Specific Models.- Methods for Measuring the Components and Profile of Drug Actions: The Multivantaged Approach.- The Component-Specific Model Applied in a Clinical Trial: An Example.- Comparing the Component-Specific Model Directly with the Established Diagnosis-Specific Trial.- Prediction and Shortening the Clinical Trial: Further Advantages of the Component-Specific Model.- The Video Clinical Trial and the VIBES Method.- Conclusions.
Martin M. Katz received his A.B. degree in Chemistry at Brooklyn College and his Ph.D. from the University of Texas in Psychology and Physiology. From 1958 to 1968, he served in the National Institute of Mental Healths (NIMH as Executive Secretary of its first Psychopharmacology Advisory Committee, then, in 1965, as Head of its Special Studies section in Psychopharmacology. In 1968 he was appointed Chief, of the Institutes Clinical Research Branch, a new program charged with expanding research on the causes and treatment of schizophrenia and the affective disorders. It initiated national conferences and developed Collaborative Programs on the Psychobiology of Depression laying the groundwork for the new DSM and large scale testing of the new biochemical theories of the genesis of the disorders. The Biology and Clinical Collaborative Programs created by Dr. Katz and Branch Staff (1970-1978), were responsible for the training of many young investigators, and provided needed methodology for expanding research in these fields. The Clinical Aspect of the Program was still, thirty years later, in operation under an NIMH grant. In 1984, he joined the Psychiatry faculty at Albert Einstein College of Medicine as Professor establishing the first Division of Psychology and Laboratory of Psychopathology at the College. Since 1996, he has been Adjunct Research Professor in the Department of Psychiatry, University of Texas Health Science Center at San Antonio, where he has conducted grant-supported research on the Biological Aspects of Depression and the neurobehavioral mechanisms of action of antidepressant drugs.
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