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008 150127s2015 enk ob 001 0 eng d
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016 7 _a101662180
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019 _a1066445834
_a1088979503
020 _a9780124051768
_q(electronic bk.)
020 _a0124051766
_q(electronic bk.)
020 _z9780124051706
020 _z0124051707
035 _a(OCoLC)900781265
_z(OCoLC)1066445834
_z(OCoLC)1088979503
050 4 _aRC512
_b.C55 2015eb
060 0 0 _a2015 F-907
060 1 0 _aWM 207
072 7 _aPSY
_x022030
_2bisacsh
082 0 4 _a616.89
_223
245 0 0 _aClinical trial design challenges in mood disorders /
_h[electronic resource]
_cedited by Mauricio Tohen, Charles L. Bowden, Andrew A. Nierenberg, John R. Geddes.
264 1 _aLondon, UK :
_bAcademic Press,
_c[2015]
300 _a1 online resource
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
588 0 _aVendor-supplied metadata.
504 _aIncludes bibliographical references and index.
520 _aPoor 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.
505 0 _a<P>Preface</p> <p>Chapter 1: Clinical Trial Design of Maintenance Treatments in Bipolar Disorder Mauricio Tohen</p> <p>Chapter 2: Meta-Analysis of Clinical Trials in Bipolar Disorder John R. Geddes</p> <p>Chapter 3: Effectiveness Trials in Bipolar Disorders Andrew A. Nierenberg</p> <p>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</p> <p>Chapter 5: The Role of Noninferiority Designs in Bipolar Disorder Clinical Trials Edward Vieta and N�uria Cruz</p> <p>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</p> <p>Chapter 7: Sequential Multiple Assignment Randomized Treatment (SMART): Designs in Bipolar Disorder Clinical Trials Charles L. Bowden and Vivek Singh</p> <p>Chapter 8: Novel Study Designs for Clinical Trials in Mood Disorders Hong Jin Jeon and Maurizio Fava</p> <p>Chapter 9: Rating Scales in Bipolar Disorder Martha Sajatovic, Peijun Chen and Robert C. Young</p> <p>Chapter 10: Clinical Applicability of Results from Drug Trials in Bipolar Disorder -- An Attempt to Shed Light on a Complex Issue Rasmus Wentzer Licht</p> <p>Chapter 11: Clinical Trials in Developing Countries: Challenges in Design, Execution, and Regulation Chittaranjan Andrade and Tim Appaiah</p>
650 0 _aAffective disorders.
650 0 _aManic-depressive illness.
650 7 _aPSYCHOLOGY
_xPsychopathology
_xBipolar Disorder.
_2bisacsh
650 7 _aAffective disorders.
_2fast
_0(OCoLC)fst00798861
650 7 _aManic-depressive illness.
_2fast
_0(OCoLC)fst01007706
650 1 2 _aBipolar Disorder
_xtherapy.
_0(DNLM)D001714Q000628
650 2 2 _aMood Disorders
_xtherapy.
_0(DNLM)D019964Q000628
650 2 2 _aClinical Trials as Topic.
_0(DNLM)D002986
655 0 _aElectronic book.
655 4 _aElectronic books.
655 7 _aElectronic books.
_2lcgft
700 1 _aTohen, Mauricio,
_eeditor.
700 1 _aBowden, Charles L.,
_eeditor.
700 1 _aNierenberg, Andrew A.
_q(Andrew Alan),
_d1955-
_eeditor.
700 1 _aGeddes, John R.,
_eeditor.
776 0 8 _iPrint version:
_tClinical trial design challenges in mood disorders.
_dLondon, England : Academic Press, c2015
_hxi, 179 pages
_z9780124051706
_w2014946465
856 4 0 _3ScienceDirect
_uhttp://www.sciencedirect.com/science/book/9780124051706
999 _c247039
_d247039