The Journal of clinical psychiatry
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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.
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A substantial proportion of depressed patients show only partial or no response to antidepressants, and even among responders to antidepressant treatment, residual symptoms are rather common. When depressions do not respond adequately to treatment with an antidepressant, clinicians may choose to keep the same antidepressant and add another "augmenting" compound. Such augmentation strategies involve the use of a pharmacologic agent that is not considered to be a standard antidepressant but may boost or enhance the effect of an antidepressant. ⋯ These strategies typically aim at obtaining a different neurochemical effect than the one obtained with the antidepressant that has not produced adequate response. While drug-drug interactions may limit the use of some of these strategies, the potential loss of partial benefit from the failed drug inherent in switching may increase the acceptability of augmentation and combination strategies among partial responders. Further studies are clearly needed to evaluate the comparative efficacy and tolerability of these different approaches in treatment-resistant depressions.
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Chronic depression, which is marked by a course of illness lasting 2 years or more, encompasses 4 subtypes of depressive illness: (1) chronic major depressive disorder, (2) dysthymic disorder, (3) dysthymic disorder with major depressive disorder ("double depression"), and (4) major depressive disorder with poor interepisodic recovery (i.e., in incomplete remission). In the 1990s, chronic depression had a reported prevalence rate of 3% to 5% and accounted for 30% to 35% of all cases of depression in the United States. The authors present an algorithm modified from the Texas Medication Algorithm Project for patients with chronic depression. ⋯ The first stage is monotherapy with the selective serotonin reuptake inhibitors, nefazodone, bupropion sustained release, venlafaxine extended release, mirtazapine, or psychotherapy. Later options include combination therapy, electroconvulsive therapy, atypical antipsychotics, and novel treatments. Utilization of a comprehensive treatment algorithm for chronic major depression should encourage efficient, efficacious treatment.