The Handbook of Psychopharmacology Trials: An Overview of Scientific, Political, and Ethical Concerns

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Marc Hertzman, Douglas E. Feltner
NYU Press, 1997 - Medical - 454 pages
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Each year pharmaceutical companies invest billions of dollars in clinical trials of drugs used for the treatment of central nervous system diseases. Due to enormous progress in basic pharmaceutical research in recent years, controlled tests of new medications are flourishing and these trials have rapidly become an intense focus of practical medical research.

Aware of the complexities presented in the design, execution, and evaluation of clinical trials, Marc Hertzman and Douglas E. Feltner bring together a collection of essays that dissect the scientific, psychosocial, political, and ethical concerns that must be examined for any CNS trial. The internationally known contributors examine concerns about ethics and cost; the FDA and its regulatory impact; and the implementation of a variety of trials, for disorders such as schizophrenia, alcoholism, eating disorders, insomnia, and aggression. The editors carefully consider important social issues including the considerations related to women's special needs; and the relative merits of psychotherapy and medications.

The Handbook of Psychopharmocology Trials provides an up-to- date and stimulating exploration of important issues on the subject of CNS Clinical trials.

  

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Contents

One The Importance of Clinical Trials for Central
3
Two Ethical Considerations of Federal Guidelines
23
Central
46
Five CNS Clinical Drug Trials and Women
100
Six The Placebo Effect in Drug Trials and
123
Seven The Clozapine Story
137
Eight Clinical Trials of Typical Neuroleptics
157
Nine Pharmacologic Treatment of Depression
192
Ten Methodological Issues in Pharmacotherapy
213
Eleven Conducting Clinical Drug Trials in
246
Twelve Assessing Pharmacotherapy in Insomnia
268
Medications and Psychotherapy
315
Fifteen What Are We Doing? A Closer Look at
348
Sixteen New Molecules and New Therapies
377
Index
425
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About the author (1997)

Marc Hertzman is Clinical Professor of Psychiatry at the University of Maryland, and Medical Director of Psychiatry at the North Arundel Hospital in Glen Burnie, Maryland. Douglas E. Feltner is a Howard Hughes Medical Institute postdoctoral Fellow at the National Institutes of Health, and Assistant Clinical Professor of Psychiatry at George Washington University.

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