Clinical Trials in Psychopharmacology: A Better Brain
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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
mortality is the endpoint for determining suicide (and it is clearly, by far, the best), the difference between simply tallying the number of deaths versus the number of suicides is an enormous gulf. The moment a death is deemed a suicide, the statement implies a reasonable likelihood of intent. Unfortunately, there is a vast, murky literature about determining the seriousness of intent. Many claims have been made about the ability of a variety of questionnaires, especially before-the-fact, to
series of clinical papers appeared which reviewed a variety of trials of antidepressants for treatment of children and adolescents diagnosed with depression in various guises. This was a noteworthy and valuable area in which to work because, for many years, antidepressants simply were not tested in anyone but adults during clinical trials toward drug licensure. On the one hand, the reasoning was that minors are too vulnerable and should not be subjected to unconﬁrmed experimental treatments.
antispsychotics (risperidone, olanzapine, ziprasidone and aripiprazole) [90, 91]; dopamine agonists (pramipexole) ; and others (pindolol, psychostimulants, buspirone, modaﬁnil, testosterone and estrogens) . The drugs most commonly used for augmentation are lithium and thyroid hormones (T3). Some non-pharmacologic treatments of resistant depression have been studied: electroconvulsivotherapy (possibly the most effective treatment for resistant depression with higher response rates than
depressive and anxiety disorders  found no group difference between African American, Asian Americans and Latinos. Finally, it should be noted that ethnic minorities tend to dropout from pharmacological trials more often, even if the reasons are not clear . Clinical evidence is therefore still poor for an ethnic difference in efﬁciency and tolerability. However, clinicians should be aware of ethnic pharmacological variability, for example the low metabolism of drugs interacting with the
may experience and the range of treatments they may receive. A better understanding of the complex interplay between effectiveness, safety, quality of life, adherence and resource use should ultimately contribute to improving treatment. Another review  concluded that, notwithstanding the substantial evidence that bipolar disorder is associated with signiﬁcant impairment to functioning and well-being, few clinical trials comparing treatments for bipolar disorder have incorporated