Clinical Trial Design Challenges in Mood Disorders

Mauricio Tohen, MD, DrPH, MBA is the Chairman of the Department of Psychiatry at the University of New Mexico Health Sciences Center in Albuquerque NM, USA.Dr Tohen was born and raised in Mexico City. He earned his medical degree from the National University of Mexico and his Doctorate in Public Health (Epidemiology) from Harvard University. His postdoctoral training included a residency in Psychiatry at the University of Toronto and a fellowship at McLean Hospital, Harvard Medical School. Dr Tohen also obtained an MBA degree from the Indiana University Kelly School of Business.Dr Tohen was the Clinical Director of the Bipolar and Psychotic Disorders Program at McLean Hospital (1988-1997). In 1997 he joined Lilly Research Laboratories where he reached the senior most scientific rank of Distinguished Lilly Scholar. From 2009-2013 he was the Head of the Division of Mood & Anxiety Disorders and the Krus Endowed Tenured Professor in Psychiatry at the University of Texas Health Science Centre at San Antonio.Among numerous awards, Dr Tohen received a National Service Award in Psychiatric Epidemiology from the National Institute of Mental Health (NIMH) and Harvard University. He also received a FIRST award from NIMH, the Pope Award from McLean Hospital, a NARSAD Young Investigator Award and in 2011 the Simon Bolivar Award from the American Psychiatric Association for outstanding contribution to education, research and overall achievement in Psychiatry and leadership in Hispanic Psychiatry. From 2010 to 2012, Dr Tohen was the President of the International Society for Bipolar Disorders. He is the President of the American Society of Hispanic Psychiatry (2014-2016).Dr Tohen's research, supported by grants from NIMH, private foundations and the pharmaceutical industry, has focused on the epidemiology, outcome, and treatment of Bipolar and Psychotic Disorders. He has authored more than 250 original publications and edited or co-edited four books including Mood Disorders Across the Life Span (1996), Comorbidity in Affective Disorders (1999), Bipolar Disorder: The Upswing in Research and Treatment (2005), Bipolar Psychopharmacotherapy (first edition 2006, second edition 2011), and Psychiatric Epidemiology (first edition 1995, second edition 2003, third edition 2011).In 2014 he was in the top 100 most cited researchers worldwide for the last decade in the field of Psychiatry and Psychology and selected as a Thomson Reuters Highly cited researcher and also in the 2014 list of World’s Most influential Scientific Minds.

• Preface 1. Clinical Trial Design of Maintenance Treatments in Bipolar DisorderMauricio Tohen 2. Meta-Analysis of Clinical Trials in Bipolar DisorderJohn R. Geddes 3. Effectiveness Trials in Bipolar DisordersAndrew A. Nierenberg 4. Long-Term Treatment of Mood Disorders: Follow-Up of Acute Treatment Phase Studies Versus Continuation and Maintenance Phase Studies, and Enriched Versus Non-Enriched DesignsWillem A. Nolen and Heinz Grunze 5. The Role of Noninferiority Designs in Bipolar Disorder Clinical TrialsEdward Vieta and Núria Cruz 6. The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical TrialsMichael Berk, Reneé Otmar, Olivia Dean, Lesley Berk and Erin Michalak 7. Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical TrialsCharles L. Bowden and Vivek Singh 8. Novel Study Designs for Clinical Trials in Mood DisordersHong Jin Jeon and Maurizio Fava 9. Rating Scales in Bipolar DisorderMartha Sajatovic, Peijun Chen and Robert C. Young 10. Clinical Applicability of Results from Drug Trials in Bipolar Disorder - An Attempt to Shed Light on a Complex IssueRasmus Wentzer Licht 11. Clinical Trials in Developing Countries: Challenges in Design, Execution, and RegulationChittaranjan Andrade and Tim Appaiah