Main description:

The book reviews clinical trial methodology as it pertains to drug development in psychiatry. The reader will understand the process of drug development in psychiatry from discovery through marketing with the help of clinically relevant examples. The reader will appreciate the history of drug development in psychiatry dating back to the era of serendipitous discovery and culminating in an era of new and highly focused targets. Readers will understand how drug development in psychiatry has changed and adapted with the discovery of novel mechanism of action drugs. Novel drugs and disease targets have changed the way developers and regulatory agencies think about clinical trial methodology.

The book elucidates how biomarkers, genetics and advances in neuroscience and neuroimaging have influenced drug development approaches, which will ultimately change the practice of psychiatry. The book will be broken down into the following sections:

a. Prior to the 1960s - Drug discovery by chance observation

b. The last 50 years - refined targeting of CNS drugs without the discovery of mechanistically new drugs

c. The future - the discovery and development of mechanistically new drugs. The examination of new targets, genetics and biomarkers.

Contents:

Contents

1. Chapter 1: Drug Development in Psychiatry: The Long and Winding Road from Chance Discovery to Rational Development

Author: Sheldon H. Preskorn

2. Chapter 2: The History of Drug Development in Psychiatry: A Lesson in Serendipity

Author: Abhishek Wadhwa, MD* (Corresponding author)

3. Chapter 3: The Evolving Role of Animal Models in the Discovery and Development of Novel Treatments for Psychiatric Disorders

Author: Laura Teal, Shalonda Ingram, Michael Bubser, Elliott McClure and Carrie K. Jones* (Corresponding author)

4. Chapter 4: Discovery and Development of Monoamine Transporter Ligands

Author: Dr Mortensen* and Dr. Aggarwal* (*Corresponding authors)

5. Chapter 5: Drug Development for New Psychiatric Drug Therapies

Author: M. Lynn Crismon (Corresponding author), Janet Walkow, Roger Sommi

6. Chapter 6: Post-Approval Research in Drug Development: Priorities and Practices

Author: David Williamson (Corresponding author), Jack Sheehan, and Ella Daly

7. Chapter 7: Discovery of new transmitter systems and hence new drug targets

Author: Tiffany Schwasinger-Schmidt (Corresponding author) and Sheldon Preskorn

8. Chapter 8: Reverse engineering drugs

Author: Tiffany Schwasinger-Schmidt (Corresponding author) and Sheldon Preskorn

9. Chapter 9: Back to the Future of Neuropsychopharmacology

Author: Anton Bespalov (Corresponding author), Marcel van Gaalen, Thomas Steckler

10. Chapter 10: Targeted Treatments for Fragile X Syndrome

Author: Devon Johnson MD (Corresponding author), Courtney Clark BS, Randi Hagerman MD

11. Chapter 11: The Difficult Path to the Discovery of Novel Treatments in Psychiatric Disorders Diseases

Author: Valentin K. Gribkoff* and Leonard K. Kaczmarek* (*Corresponding authors)

12. Chapter 12: Biomarkers in Psychiatric Drug Development: From Precision Medicine to Novel Therapeutics

Author: Rudy Lozano Carreon, M.D., Ana Maria Rivas-Grajales, M.D., Nicholas Murphy, Ph.D., Sanjay J. Mathew, M.D., Manish K. Jha, M.B.B.S. (Corresponding author)

13. The role of fMRI in drug development: an update

Author: Owen Carmichael (Corresponding author)

14. Monoamine Oxidase B (MAO-B): A Target for Rational Drug Development in Schizophrenia Using PET Imaging as an Example

Author: Kankana Nisha Aji, Jeffrey H. Meyer, Pablo M. Rusjan , Romina Mizrahi (Corresponding author)

15. Genomics in Treatment Development

Author: Yogesh Dwivedi, PhD and Richard C. Shelton, MD (Corresponding author)

16. Increased Inflammation and Treatment of Depression: from Resistance to Reuse, Repurposing and Redesign

Author: Jennifer C. Felger, Ph.D., M.S. (Corresponding author)

17. Experimental medicine approaches in early phase CNS drug development

Author: Brett A. English (Corresponding author) and Larry Ereshefsky