Psychotropics efficacy

The role of ethnopharmacology in the identification of plant-derived hallucinogens (psychotomimetics) has been extensively reviewed elsewhere [15]. To date, however, efforts to identify or rigorously characterize natural product-derived treatments with psychotropic efficacy have been sporadic at best in most western nations. The reasons for this are complex and include, among others ... 

Conversely, anecdotal reports of putative psychotropic efficacy found outside the mainstream scientific-technical literature will assist the critical student in his efforts to maintain rigor when reading about effects reported... 

Significant ethnopharmacologic research efforts are ongoing in diverse settings around the world to characterize the psychotropic efficacy of... 

Klotz U, Avant GR, Hoyumpa Aet al. (1975) The effects of age and liver disease on the disposition and elimination of diazepam in adult man. J Clin Invest 55(2) 347-359 Kompoliti K and Goetz CG (1998) Neuropharmacology in the elderly. Neurol Clin 16(3) 599-610 Lanctot KL, Best TS, Mittmann N et al. (1998) Efficacy and safety of antipsychotics in behavioral disorders associated with dementia. J Clin Psychiatry 59(10) 550-561 Landi F, Onder G, Cesari M et al. (2005) Psychotropic medications and risk for falls among community-dwelling frail older people an observational study. J Gerontol A Biol Sci Med Sci 60(5) 622-626... 

Clinical Trials and their Importance in Assessing the Efficacy and Safety of Psychotropic Drugs... 

The placebo is useful in (a) distinguishing the pharmacod)mamic effects of a drug from the psychological impact of the medication and the environment in which it is given (the "halo" effect of the enthusiastic, or pessimistic, research clinician). It is well known, for example, that the placebo effect in major depression is as high as 30% while that of an effective antidepressant is approximately 60% of the optimal response. This statistic illustrates the importance of placebo-based studies in evaluating the efficacy of a new psychotropic drug. 

Serendipity has played a major role in the discovery of most classes of psychotropic drugs. For example, the observation that the first antidepressants, the tricyclic antidepressants and the monoamine oxidase inhibitors, impeded the reuptake of biogenic amines into brain slices, or inhibited their metabolism, following their acute administration to rats, provided the experimenter with a mechanism that could be easily investigated in vitro. Such methods led to the development of numerous antidepressants that differed in their potency, and to some extent in their side effects (for example, the selective serotonin reuptake inhibitors) but did little to further the development of novel antidepressants showing greater therapeutic efficacy. The accidental discovery of atypical antidepressants such as mianserin led to the broadening of the basis of the animal models... 

Psychotropic medication use is associated more with causing difficulties with eating rather than as a treatment for eating disorders. None of the medications investigated in the treatment of primary anorexia nervosa have been shown to be efficacious. Pica is defined as the eating of non-food substances. In the Expert Consensus survey (Rush and Frances, 2000) 63% of the respondents stated that no medication treatment is indicated for this disorder. Should medication be considered, then SSRI medications were most commonly endorsed. Another alternative is treatment with mineral or nutritional supplements, such as zinc or iron. 

Aman, M.G. (1993) Efficacy of psychotropic drugs for reducing self-injurious behavior in the developmental disabilities. Ann Clin Psychiatry 5 171-188. 

Despite these data showing surprisingly extensive use of psychotropic medications, there are no adequate studies of either the efficacy or safety of these medications in the preschool population. Two important questions raised by Zito et ah, were (1) what clinical entities are being treated with psychotropics in the 2-4-year-old population, and (2) is the absolute use and increase in use justified The publication of this paper in February 2000, raised sufficient concern to provoke the planning and conduct of several meetings focused at least in part on this topic in the fall of 2000. 

While the issue of the ethical conduct of clinical trials in pediatric psychopharmacology is addressed comprehensively elsewhere in this book, it is important to present an FDA perspective on this important matter. It is also important to have the issue of ethics discussed in the context of the scientific needs for trials presented to the FDA in support of new drug applications. These trials must be adequate and well-controlled (U.S. Department of Health and Human Services, 2001). What this requirement essentially means is that, in order to support an efficacy claim, the trials must be interpretable and must be able to document efficacy. For treatments that are intended to improve symptoms, as is almost always the case for psychotropic drugs, placebo-controlled trials are the usual standard. This is especially true when there is a substantial failure rate in placebo-controlled trials for the drugs known to work in a particular therapeutic area, as again is the case for most psychotropic drugs. Where that is true,... 

Lambert 1984 McElroy et al. 1988b] suggested that valproate may be a much better antimanic than antidepressant agent. In a study of 78 consecutively recruited patients with rapid-cycling bipolar disorder treated with open-label valproate alone or in combination with other psychotropic agents, Calabrese and colleagues [Calabrese and Delucchi 1990 Calabrese et al. 1992] reported a 54% valproate response in acute mania, an 87% response in acute mixed states, and a 19% response in acute depression. However, they did observe a prophylactic antidepressant effect in patients subsequently. Additional controlled studies are needed to clarify valproate s antidepressant efficacy. 

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