Clinical Trial Design Challenges in Mood Disorders

Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders.  Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results.  Traditional trial designs are included as well as novel analytic techniques.  The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice.  With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients.

Summarizes common trial design problems and their solutionsEncompasses funding, subject selection, regulatory issues and moreIdentifies best practices for definitive and generalizable resultsIncludes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

Preface

Chapter 1: Clinical Trial Design of Maintenance Treatments in Bipolar Disorder Mauricio Tohen

Chapter 2: Meta-Analysis of Clinical Trials in Bipolar Disorder John R. Geddes

Chapter 3: Effectiveness Trials in Bipolar Disorders Andrew A. Nierenberg

Chapter 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 Designs Willem A. Nolen and Heinz Grunze

Chapter 5: The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials Edward Vieta and Núria Cruz

Chapter 6: The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials Michael Berk, Reneé Otmar, Olivia Dean, Lesley Berk and Erin Michalak

Chapter 7: Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials Charles L. Bowden and Vivek Singh

Chapter 8: Novel Study Designs for Clinical Trials in Mood Disorders Hong Jin Jeon and Maurizio Fava

Chapter 9: Rating Scales in Bipolar Disorder Martha Sajatovic, Peijun Chen and Robert C. Young

Chapter 10: Clinical Applicability of Results from Drug Trials in Bipolar Disorder - An Attempt to Shed Light on a Complex Issue Rasmus Wentzer Licht

Chapter 11: Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation Chittaranjan Andrade and Tim Appaiah