International clinical psychopharmacology
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Int Clin Psychopharmacol · Sep 2018
Review Historical ArticleThe conundrum of depression clinical trials: one size does not fit all.
In this paper we review the history of antidepressant (AD) development, since the discovery of imipramine in 1957 to the present day. Through this exploration we will show that the increasing placebo response is likely a red herring and that a higher magnitude of placebo response is not an adequate explanation for AD trials' high failure rates. ⋯ In addition, we describe the lack of precision in the depression outcome measurements for the past 40 years and show how these measures contrast with those used in clinical trials of other chronic diseases, which use simpler outcome measures. Finally, we describe the role of regulatory agencies in influencing clinical trial design and how the assumption that 'one size fits all' for the past 60 years has led to flawed design of AD clinical trials.
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Int Clin Psychopharmacol · Sep 2018
ReviewA review and study of aspirin utilization for the primary prevention of cardiovascular events in a psychiatric population.
In April 2016, the US Preventive Service Task Force (USPSTF) updated the aspirin guidelines for the primary prevention of cardiovascular disease (CVD) and colorectal cancer. This review assesses the importance of appropriate use of aspirin for the primary prevention of CVD and, specifically, how individuals with psychiatric disorders may benefit from such use. This study examined how current prescribing practices of aspirin in a state psychiatric hospital align with these new guidelines and how inappropriate prescribing may jeopardize patient safety. ⋯ Overutilization did not pose a serious risk for those on aspirin therapy in this sample, as there were no major episodes of bleeding. However, future harm from aspirin still exists based on the significant number of major and moderate potential drug interactions with aspirin and the increased risk of decreased adherence to critical psychiatric medications due to increased pill burden and regimen complexity. Our findings demonstrate that there is an opportunity to educate prescribers on the updated 2016 USPSTF guidelines to improve preventive care and patient safety, which include harm reduction by initiating aspirin in those who are at a risk of cardiovascular events, continuing aspirin in those who are currently receiving aspirin appropriately, and discontinuing aspirin in those who are not considered to be at a high risk of CVD and who may also be at a risk of experiencing an increased risk of bleeding.