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
O autorze
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.
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