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Clinical trial design challenges in mood disorders / [electronic resource] edited by Mauricio Tohen, Charles L. Bowden, Andrew A. Nierenberg, John R. Geddes. - 1 online resource

Includes bibliographical references and index.

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 N�uria Cruz

Chapter 6: The Use of Mixed Methods in Drug Discovery: Integrating Qualitative Methods into Clinical Trials Michael Berk, Rene�e 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



Poor clinical trial designs result in failed studies wasting hundreds of thousands of dollars in research funds. Poor clinical trial designs limit the rapid advancement of cures for disorders. Yet it's relatively easy to avoid classic poor designs via education about what constitutes good design and what the potential outcomes are for any shortcuts taken. The proposed book outlines the classic problems that researchers are faced with in designing clinical trials, whether its money, selection of subjects, regulatory issues etc, and how best to address them for the most definitive and generalizable results. This book is specific to clinical trial issues in psychiatric research, and comes from a task force in Bipolar Research. The contents herein were identified as the most major issues in psychiatric research. Authored by international contributors from academia, industry, regulatory agencies, and advocacy groups, this book summarizes problems in clinical design and the results of same, and whether and how the results can be applied into clinical practice.

9780124051768 0124051766

2015458943

101662180 DNLM


Affective disorders.
Manic-depressive illness.
PSYCHOLOGY--Psychopathology--Bipolar Disorder.
Affective disorders.
Manic-depressive illness.
Bipolar Disorder--therapy.
Mood Disorders--therapy.
Clinical Trials as Topic.


Electronic book.
Electronic books.
Electronic books.

RC512 / .C55 2015eb

616.89

2015 F-907 WM 207
Last Updated on September 15, 2019
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