The Journal of clinical psychiatry
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Review Comparative Study
Risperidone for the treatment of behavioral and psychological symptoms of dementia.
Risperidone offers physicians the unique combination of extensive, published clinical experience and a good safety profile for treating patients with dementia who have symptoms of aggression, agitation, and psychosis. Numerous open-label and, more recently, placebo-controlled trials have documented the efficacy of risperidone in the management of behavioral and psychological symptoms of dementia. These trials also show that risperidone is better tolerated than conventional neuroleptic agents. Comparatively, patients treated with risperidone experience substantially fewer side effects, including extrapyramidal symptoms, cognitive toxicity, and tardive dyskinesia.
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Randomized Controlled Trial Clinical Trial
Melatonin in medically ill patients with insomnia: a double-blind, placebo-controlled study.
It has been suggested that melatonin improves sleep functioning, but this possibility has not been studied in medical populations. ⋯ Melatonin may be a useful hypnotic for medically ill patients with initial insomnia, particularly those for whom conventional hypnotic drug therapy may be problematic.
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Review
United States Food and Drug Administration requirements for approval of generic drug products.
As generic products become more available for the treatment of psychiatric disorders, clinicians must stay abreast of the U. S. ⋯ The rationale behind the overall concept of bioequivalence is that if 2 pharmaceutical equivalents provide identical plasma concentration-time profiles in humans, there is no evidence to demonstrate that the 2 identical dosage forms will exhibit a difference in safety and efficacy. This article reviews current terminology used in abbreviated new drug applications for generic products, typical bioequivalence study designs, and FDA bioequivalence guidance for clozapine.
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Review Comparative Study
The epidemiology of posttraumatic stress disorder: what is the extent of the problem?
Until recently, our understanding of posttraumatic stress disorder (PTSD) relied almost entirely on studies of war veterans and disaster victims. A handful of epidemiologic studies have now been conducted that investigate the natural course of PTSD as it occurs in the general population. ⋯ This article reviews key findings from these studies to provide insight into the burden of PTSD in the general population. Possible reasons for the observed difference in lifetime prevalence of PTSD between the sexes (a female-to-male lifetime prevalence ratio of 2:1 is typically reported) and factors thought to be associated with an increased risk for the disorder after exposure to trauma are reviewed.
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Assessing the consequences of specific diseases on global, national, and individual levels is complex. The Global Burden of Disease Study was launched in 1992 to develop objective measures of the burden of disease. Two measures have become widely accepted: disability-adjusted life-years (DALYs) assesses years of life lost due to a disease plus years lived with the disability due to that disease, and years lived with disability (YLDs) is a related measure with greater relevance for diseases that do not routinely produce earlier mortality. ⋯ The contributions to the morbidity associated with major depressive disorder and treatment-resistant depression include widespread prevalence; relatively early symptom onset; severe underdiagnosis and undertreatment; genetic vulnerabilities and precipitation or accentuation by relatively unavoidable stressors; a longitudinal pattern of frequent recurrences with increasing frequency, severity, and consequences unless treated with maintenance strategies; inadequate prioritization of recurrence prevention among clinicians; and possible suppression of brain neurogenesis, neuronal atrophy, cell death, hippocampal dysfunction, and magnetic resonance imaging changes for those with chronic treatment-resistant depression. Since the patterns of recurrences, cycle acceleration, and increasing severity of treatment-resistant depression are key reasons for its high burden, reducing the burden requires an entire paradigm shift, including emphasis on the prevention of recurrences. Only then will this prevalent, disabling yet treatable disorder lose its ignominious status as a world leader in disease burden.