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.
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Int Clin Psychopharmacol · May 2017
Observational StudyClinical factors related to acute electroconvulsive therapy outcome for patients with major depressive disorder.
The aim of this study was to explore the significant predictors associated with electroconvulsive therapy (ECT) outcome for patients with major depressive disorder. Major depressive disorder inpatients (N=130) requiring ECT were recruited from a major psychiatric center in South Taiwan. ECT was generally performed for a maximum of 12 sessions. ⋯ Patients with treatment-resistant depression, longer duration of the current depressive episode, and higher levels of pain were more likely to have less symptom reduction after acute treatment with ECT, irrespective of how the depressive symptoms were rated using HAMD-17 or CGI-S. To improve efficacy, earlier application of ECT and pain control should be considered during an acute course of ECT. Other clinical predictors related to ECT outcome require further investigation in future studies.
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Int Clin Psychopharmacol · Jan 2017
Meta AnalysisEarly improvement with pregabalin predicts endpoint response in patients with generalized anxiety disorder: an integrated and predictive data analysis.
Generalized anxiety disorder (GAD), a common mental disorder, has several treatment options including pregabalin. Not all patients respond to treatment; quickly determining which patients will respond is an important treatment goal. Patient-level data were pooled from nine phase II and III randomized, double-blind, short-term, placebo-controlled trials of pregabalin for the treatment of GAD. ⋯ Response to pregabalin in the first 1-2 weeks (≥20 or ≥30% improvement in HAM-A total, psychic or somatic score) was predictive of an endpoint greater than or equal to 50% improvement in the HAM-A total score. Pregabalin is an effective treatment option for patients with GAD. Patients with early response to pregabalin are more likely to respond significantly at endpoint.
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Int Clin Psychopharmacol · Jul 2016
Randomized Controlled Trial Multicenter StudyThe effect of brexpiprazole (OPC-34712) and aripiprazole in adult patients with acute schizophrenia: results from a randomized, exploratory study.
The aim of this study was to explore the effects of brexpiprazole and aripiprazole on efficacy, cognitive functioning, and safety in patients with acute schizophrenia. Patients who would benefit from hospitalization/continued hospitalization for acute relapse of schizophrenia were enrolled and randomized (2 : 1) to target doses of open-label brexpiprazole 3 mg/day or aripiprazole 15 mg/day for 6 weeks. Outcomes included change from baseline to week 6 in the Positive and Negative Syndrome Scale total score, Barratt Impulsiveness Scale 11-item score, and Cogstate computerized cognitive test battery scores. ⋯ Brexpiprazole was well tolerated and the incidence of akathisia was lower in patients treated with brexpiprazole (9.4%) than aripiprazole (21.2%). Clinically relevant improvements in psychopathology were observed in patients with acute schizophrenia treated with brexpiprazole or aripiprazole. Brexpiprazole was well tolerated, with a lower incidence of akathisia than aripiprazole.