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Clinical Trials of Antidepressants:

How Changing the Model Can Uncover New, More Effective Molecules

Reviewed by Martin M. Katz

INFORMATION ON CONTENT:      This brief book makes note of recent failures and abandonment by many companies of antidepressant drug development. It takes current clinical trial protocols to task and replaces them with a contemporary framework for improving next-generation antidepressants and their underlying science. New, innovative models are based on a neurobehaviorally-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, from a “holistic” to a “dimensional” model. These changes are essential to bring pharmaceutical research and development up to date, in order to boost efficiency and effectiveness in finding new molecules, and reducing waste. In proposing a new theory of depression, it brings decades of research on onset and specificity of dug actions current, illustrating the application of the new models with case studies and a review of salient depression methods. It is a follow-up to the author’s earlier, more conceptionally-oriented treatment of the subject in his book, Depression and Drugs (Springer, 2013), demonstrating 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 and video approaches.

•     Achieving the ideal clinical trial: an example of the merged componential and established models.

•     Prediction and shortening the clinical trial.

•     The video clinical trial.

 

AUTHOR”S COMMENT: This new book was designed to follow-up the author’s earlier treatise: Depression and Drugs: The Neurobehavioral Structure of a Psychological Storm (Springer, 2013). It is intended, in part, to apply the principles, the new theory of “opposed  neurobehavioral states“ and the methodology developed to test that theory and to manage the thorny problems associated with the evaluation of new putative antidepressants. The multivantaged (MV) and video models for evaluation are described in the first book and illustrated in more detail in the new presentation, complete with case studies so that the reader can more easily follow the procedures. It is hoped that these “new” models can advance the science and introduce greater efficiency into the trial process, thus, encouraging the development of more effective and more rapidly-acting drugs.

Martin M. Katz
February 25, 2016