Clinical Trials in Psychopharmacology (eBook, PDF)

A Better Brain
Redaktion: Hertzman, Marc; Adler, Lawrence

• Format: PDF

Produktbeschreibung

Although clinical trials were virtually unheard of in psychiatry for many years, they are now the gold standard for judging whether drugs are safe and useful. But should they be? What is the true status of clinical trials? Even when they ostensibly demonstrate a benefit of a certain treatment, the strict patient selection criteria, poor compliance and high drop-out rate leave the conclusions open to question. Are the new treatments really better or more cost-effective than the old? Do they have fewer side effects? In this book the authors take a critical look at recent developments and present a series of trenchant and challenging observations. Section I examines the significant changes in law and the regulatory environment that have occurred during the past ten years. Has fossilization handicapped the US Food and Drug Administration in promoting treatment advances? How can the plethora of findings be regulated? This is particularly pertinent in genomic studies and there are two chapters addressing the impact of genomics on psychiatric research. This section also addresses the role of women in drug trials - a group long excluded but now demanding a part, for without testing how can optimal treatments be devised? The next two Sections highlight clinical trials in the major areas of psychiatric pharmacological treatment, including Mood Disorders, especially Bipolar, Anxiety Disorders, and addictions. Chapters on pharmacological treatments for Eating Disorders, Attention Deficit Disorder, Autism and Asperger's Syndrome, and Impulse Control Disorder represent the latest thinking on these subjects. The final Section contains a consummate example of out-of-the [Western]- box thinking, namely consideration of herbal medicines - used by a large number of patients, with or without medical supervision. We conclude with a close look at the problem of side effects, then selected thoughts about methodology. Clearly written, the text provides immediate access to new developments across the spectrum of drug testing. Clinical Trials in Psychopharmacology: A Better Brain is provocative reading for psychiatrists, pharmacologists and all those interested in improved drug treatments for patients with mental illness. * Raises questions about the conduct of trials and the credibility of their outcomes that are relevant not just in psychiatry but all areas of medicine * Discusses the ethical problems in assessing outcomes in humans, including children

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 406
• Erscheinungstermin: 1. März 2010
• Englisch
• ISBN-13: 9780470749173
• Artikelnr.: 37299130

Autorenporträt

Dr. Hertzman, a psychopharmacologist, previously Professor of Psychiatry at George Washington University, is now in private practice. Before that he was a Division Director for the National Institute on Alcohol Abuse and Alcoholism and served as their representative to the US government task force which originated US policy on clinical trials. His publications, in addition to the first edition of this book, include work on Mood Disorders, Anxiety, and Autism Spectrum Disorders. He has also been a Principal Investigator on clinical trials for more than thirty years. Dr Adler is the Owner/Director of Clinical Insights and Clinical Assistant Professor of Psychiatry at the University of Maryland. He is Board-certified in Psychiatry and Geriatric Psychiatry, and is a Certified Physician Investigator. From 1983 - 1998 he conducted research into the genetics and epidemiology of schizophrenia. He has been involved in clinical trials since 1993.

Inhaltsangabe

Acknowledgments. Introduction. List of Contributors. SECTION I: The Health
Care Environment and Medications. 1. FDA Reform Déjà vu Encore (John J.
Cohrssen). 1.1 Introduction. 1.2 The 1992 prescription drug user fee act
adds funds and changes FDA's focus. 1.3 PDUFA shortens drug review times
and eliminates the drug lag. 1.4 PDUFA timetables feed safety concerns. 1.5
FDA responds to safety concerns. 1.6 The pipeline problem. 1.7 The 2007 FDA
Science Board's Subcommittee on Science and Technology report. 1.8 The
FDAAA of 2007 reauthorize PDUFA and provide new authority to address safety
and the critical path initiative. 1.9 The impact of PDFUA on FDA. 1.10
Comparative medical benefits, comparative effectiveness and FDA. 1.11 FDA
and non-inferiority trials. 1.12 FDA and CMS decisions on medicare
coverage. 1.13 Preemption: FDA's role in relation to liability litigation
in state courts. 1.14 FDA's exclusivity in allowing access to experimental
drugs. 1.15 Conclusions. 2. Do Antidepressants Cause Suicide (Marc
Hertzman). 2.1 Some definitional problems. 2.2 A brief history of the
concerns of suicidality caused by antidepressants. 2.3 Politics rears its
ugly head. 2.4 The FDA responds to fear of its own shadow. 2.5 What changes
in public policy wrought. 2.6 A funny thing happened on the way to the
forum. 2.7 Meanwhile back at the ranch. 2.8 Moral (maybe). 3. The Genome,
Genes and Brain - Tailored Drugs (Lawrence Adler). 3.1 Introduction. 3.2
Issues in new drug development. 3.3 Early development of psychiatric
pharmaceutical entities. 3.4 Advances in research technology. 3.5 Review of
genetics. 3.6 Activation of genes by signal transduction cascades. 3.7 The
human genome. 3.8 The sequencing of the genome. 3.9 DNA variation. 3.10
Genes and illness. 3.11 Genomic findings, potential targets and new drug
development. 3.12 Conclusion . 4. Patenting and Licensing Concerns in
Psychiatric Genetics (Jorge A. Goldstein and Karen R. Markowicz). 4.1
Genetic diagnoses in psychiatry. 4.2 The evolving patent landscape in
psychiatry. 4.3 Approaches to solving potential problems. 4.4 Conclusions.
5. Women's Issues in Clinical Trials (Mary Seeman). 5.1 History. 5.2
Perceived advantages of excluding women. 5.3 Change in perspective. 5.4
Have things changed?. 5.5 Progress since 1993. 5.6 Reported current
difficulties in including women. 5.7 Contraception in clinical trials. 5.8
Drugs in lactating women. 5.9 How often do women take drugs during
pregnancy?. 5.10 Ethical issues: risk/benefit analysis. 5.11 Adequate
information. 5.12 Adolescent women. 5.13 Recruitment and retention of
women. SECTION II Clinical Trials and Mood Disorders. 6. Issues and Clues
in the Pharmacological Treatment of Mood Disorders (F. Jollant, A Ionita
and P Courtet). 6.1 What do we know about mood disorders that may be
relevant for their pharmacological treatment?. 6.2 Are there clues for the
pharmacological treatment of mood disorders?. 6.3 Perspectives. 7. Bipolar
Disorder (A. Bochetta). 7.1 Trials in acute mania. 7.2 Trials in acute
bipolar depression. 7.3 Trials in maintenance of bipolar disorder. 7.4 What
is a mood stabilizer?. 7.5 What controlled trials cannot tell us about
treatment of bipolar disorder. 8. Special Issues of Research Methodology in
Bipolar Disorder Clinical Treatment Trials (R. M. Post). 8.1 Introduction.
8.2 Efficacy-effectiveness gap. 8.3 Trials for drug registration versus
those that are most clinically informative. 8.4 Needed for designs that
more optimally inform clinical practice. 8.5 'Hidden' high degrees of
treatment resistance. 8.6 Controversy about optimal designs and rating
instruments. 8.7 The traditional RCT is expensive, cumbersome and prone to
failure. 8.8 Alternative designs for pilot and proof of principle efficacy
studies. 8.9 Statistical analysis of N-of-1 trials. 8.10 Statistical
approaches to estimating necessary trial durations in individual patients.
8.11 Crossover trials for enhancing clinical informatics and statistical
power. 8.12 Carryover effects. 8.13 Long-term trend for understudy of
bipolar disorder compared to other major mental disorders. 8.14 Parallel
and pressing design issues for childhood-onset bipolar illness. 8.15
Contradictory balance between inclusiveness (for generalizability) and
homogeneity (for efficacy). 8.16 Assessing moderators and mediators. 8.17
Conclusions and implications. 9. The Utility of Low-dose Antidepressants
(Monica L. Zilberman, Clarice Gorenstein and Valentim Gentil). 9.1
Introduction. 9.2 Low dose antidepressants for chief indications. 9.3
Antidepressant use for other indications. 9.4 Emotion regulation in healthy
individuals. 9.5 Conclusion. SECTION III Clinical Trials in Anxiety and
Other Disorders. 10. Clinical Trials for Anxiety Disorders (Marco Mula and
Gionata Strigaro). 10.1 Introduction. 10.2 Methodological issues in
treatment research for anxiety disorders. 10.3 Panic disorder with/without
agoraphobia. 10.4 Generalized anxiety disorder. 10.5 Social anxiety
disorder. 10.6 Post-traumatic stress disorder. 10.7 Conclusions. 11.
Pharmacological Trials for the Treatment of Substance Use Disorders (Lisa
J. Merlo, Julia Arana and Amanda M. Stone). 11.1 Psychopharmacological
trials for the treatment of substance use disorder. 11.2 Definitions of
substance use disorders. 11.3 Introduction to psychopharmacotherapy for
SUD. 11.4 Considerations in pharmacotherapy trials for SUDs. 11.5
Conclusions and future directions. 12. Clinical Psychopharmacology of
Patients with Eating Disorders (James E Mitchell, Kristine Steffen, Scott
Engel, Ross Crosby and James Roerig). 12.1 Introduction. 12.2 Diagnostic
issues. 12.3 Methodological/statistical issues. 12.4 Pharmacotherapy
trials. 12.5 Pharmacotherapy/psychotherapy combined trials. 12.6 Summary.
13. ADHD Clinical Trials (Anne Childress). 13.1 Introduction. 13.2
Lisdexamfetamine (Vyvanse). 13.3 Methylphenidate transdermal system
(Daytrana). 13.4 Dexmethylphenidate (Focalin). 13.5 Dexmethylphenidate
extended release (Focalin XR). 13.6 Atomoxetine (Strattera). 13.7 Extended
release methylphenidate (Ritalin LA). 13.8 Modified release methylphenidate
(Metadate CD). 13.9 Mixed amphetamine salts extended release (Adderall XR).
13.10 OROS methylphenidate (Concerta). 13.11 Guanfacine extended release.
13.12 SPD465. 13.13 Modafinil. 13.14 Bupropion XL. 13.15 Discussion. 14.
Autism and Asperger's Spectrum Disorders (Marc Hertzman). 14.1
Introduction. 14.2 Individual entities versus a spectrum disorder. 14.3
Recent psychopharmacological approaches to autism and Asperger's spectrum
disorders. 14.4 Recapitulation. 15. Pharmacological Treatments of Impulse
Control Disorders (Helga Myrseth and Ståle Pallesen). 15.1 Impulse control
disorders. 15.2 Pathological gambling. 15.3 Trichotillomania. 15.4
Kleptomania. 15.5 Pyromania. 15.6 Intermittent explosive disorder. 15.7
Conclusions. SECTION IV Special Issues in Psychopharmacology. 16. Potential
Benefits of Herbal Medicine for Schizophrenia: from Empirical Observations
to Clinical Trials (Zhang-Jin Zhang, Qing-Rong Tan, Xue-Chu Zhen and Yao
Tong). 16.1 Potential benefits of herbal medicine used in the treatment of
schizophrenia. 16.2 Possible psychopharmacological mechanisms of herbal
actions. 16.3 Search strategies for herbal agents having antischizophrenic
potentials. 16.4 Specific issues in the conduct of herbal medicine trials
in schizophrenia. 16.5 Conclusions. 17. Adverse Effects of Antipsychotics
(Pierre Landry, Anne-Marie Rousseau, and Leila Skalli). 17.1 Introduction.
17.2 Pharmacology of adverse events. 17.3 Discontinuation symptoms. 17.4
Conclusion. 18. Meta Musings on Methodology (Marc Hertzman). 18.1
Criticisms of assumptions about clinical trials methodology. 18.2 Thoughts
on alternative study designs. 18.3 Conclusion: standardization can be
stultifying. Index.