Clinical Trials in Psychopharmacology - A Better Brain

Informationen zum Autor 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.   Klappentext 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 Zusammenfassung 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. Inhaltsverzeichnis 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 fe...

Inhaltsverzeichnis

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.<

Bericht

"this is a valuable addition to the monographs on clinical trial methodology and should be essential reading for all those undertaking trials of psychotropic drugs. The chapters are clearly written, the references are up-to-date and the volume comes at a price of under £50" ( Human Psychopharmacology, 2010 )

Produktdetails

• Autoren: Marc Hertzman, Marc (EDT)/ Adler Hertzman, Marc Adler Hertzman, MM Hertzman, HERTZMAN MARC ADLER LAWRENCE
• Mitarbeit: ADLER (Herausgeber), Adler (Herausgeber), Lawrence Adler (Herausgeber), Adler Lawrence (Herausgeber), Mar Hertzman (Herausgeber), Marc Hertzman (Herausgeber), Hertzman Marc (Herausgeber)
• Verlag: Wiley, John and Sons Ltd
• Sprache: Englisch
• Produktform: Fester Einband
• Erschienen: 22.01.2010
• EAN: 9780470740767
• ISBN: 978-0-470-74076-7
• Seiten: 406
• Themen: Naturwissenschaften, Medizin, Informatik, Technik > Medizin > Nichtklinische Fächer; Krankenpflege, Psychopharmaka, Psychiatrie, Neurologie, Medizin, Psychopharmakologie, Neurology, Nursing, Psychopharmacology, Biologische Psychiatrie, Medical Science, Krankenpflege i. d. Psychologie, Mental Health Nursing, Biological Psychiatry