scholarly journals Lurasidone: Ten Years Treating Adults with Bipolar Depression

2021 ◽  
Vol 7 (2) ◽  
pp. 64-74
Author(s):  
Margarida Albuquerque ◽  
João Facucho-Oliveira ◽  
Daniel Esteves-Sousa ◽  
Nuno Moura ◽  
Daniel Neto ◽  
...  

Lurasidone is an atypical antipsychotic approved in 2010 in Canada and in the USA for the treatment of adults with schizophrenia or bipolar type I disorder. In 2014 it was approved in the European Union for the treatment of patients with 13 years‑old or older, with schizophrenia. Lurasidone is a benzisothiazole derivative with a binding profile that makes it an antidepressant candidate with a low metabolic impact. In patients with bipolar disorder, depressive episodes tend to be present for the majority of the time and are difficult to treat, as shown in multiple surveys indicating that more than three quarters of patients with bipolar depression receive at least two pharmaceutical drugs and more than one third receive three or more. Some relevant international guidelines include different first‑line options in the treatment of bipolar depression, among which is lurasidone. Considering the difficulties in treating depressive episodes in bipolar disorder, the EU marketing authorization limiting the use of lurasidone in schizophrenia only and the expectable commercialization in Portugal by 2021, we aim to review the literature regarding the efficacy and advantages of lurasidone for depressive episodes of bipolar disorder and to discuss the usefulness of approving this medication as an alternative treatment approach.

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Maximilian Pilhatsch ◽  
Thomas J Stamm ◽  
Petra Stahl ◽  
Ute Lewitzka ◽  
Anne Berghöfer ◽  
...  

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839


2014 ◽  
Vol 44 (16) ◽  
pp. 3455-3467 ◽  
Author(s):  
A. Peters ◽  
L. G. Sylvia ◽  
P. V. da Silva Magalhães ◽  
D. J. Miklowitz ◽  
E. Frank ◽  
...  

Background.The course of bipolar disorder progressively worsens in some patients. Although responses to pharmacotherapy appear to diminish with greater chronicity, less is known about whether patients' prior courses of illness are related to responses to psychotherapy.Method.Embedded in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) was a randomized controlled trial of psychotherapy for bipolar depression comparing the efficacy of intensive psychotherapy with collaborative care (a three-session psycho-educational intervention). We assessed whether the number of previous mood episodes, age of illness onset, and illness duration predicted or moderated the likelihood of recovery and time until recovery from a depressive episode in patients in the two treatments.Results.Independently of treatment condition, participants with one to nine prior depressive episodes were more likely to recover and had faster time to recovery than those with 20 or more prior depressive episodes. Participants with fewer than 20 prior manic episodes had faster time to recovery than those with 20 or more episodes. Longer illness duration predicted a longer time to recovery. Participants were more likely to recover in intensive psychotherapy than collaborative care if they had 10–20 prior episodes of depression [number needed to treat (NNT) = 2.0], but equally likely to respond to psychotherapy and collaborative care if they had one to nine (NNT = 32.0) or >20 (NNT = 9.0) depressive episodes.Conclusions.Number of previous mood episodes and illness duration are associated with the likelihood and speed of recovery among bipolar patients receiving psychosocial treatments for depression.


2016 ◽  
Vol 12 (5) ◽  
pp. 285
Author(s):  
Omer Ugur ◽  
Kadir Caner Dogan ◽  
Metin Aksoy

The European Union has grown up in terms of influence and size in international politics. The size of its economy and the ever-increasing membership, have seen its ambitions grow meaning that the EU now has an international presence it did not have at its formation. It is easy to say that with the EU being an ambitious actor in international politics, the rise into prominence of climate change naturally came in handy for the EU as it provided an opportunity for the EU to assert itself and prove both its capacity and presence. The 1992 Rio Earth Summit and the withdrawal of the USA from the obligations of the Kyoto came as a blessing in disguise for the Union as it seized the moment to assert itself. Thus, in trying to understand what role the EU has or is playing in international climate change politics, there is need to assess its leadership claims and what it has done to prove these claims. To get there, the paper will navigate through a part of the discipline of International Relations (IR) to understand how it provides for a basis to explain or understand the EU’s limitations and strengths on actorness.


Author(s):  
K. Voronov

Despite the crisis, the economy of the European Union remains to be the largest in the world. The economic mechanism of the EU is rather differentiated. It has a great historical experience and possesses sufficient evolutionary robustness. Currently, the former relationships between the EU and the USA undergo substantial changes and new forms emerge. For both of them the greatest challenge is presented by China which in recent decades shows the solid rates of GDP growth. Supposedly, Chines economy will become the world largest on in the new future. Under such conditions the Old World has to conduct a persistent search for new sources of its successful macroeconomic growth.


2020 ◽  
Vol 1 (1) ◽  
pp. 11-14
Author(s):  
Syaiful Fadilah ◽  
Fatimah Haniman

Bipolar disorder in children and adolescents is a clinical disorder that causes publicmental health problems that need attention. In the last decade, bipolar disorder in children andadolescents has become a trendy field, both in the clinical area and in research, especially interms of diagnosis, which is still controversial. The controversy that remains is whether it ispossible to diagnose bipolar disorder in prepubertal children. Based on the DSM-IV-TRdiagnostic criteria, the prevalence of the bipolar disorder in children scarce rare.Epidemiological studies report the lifetime prevalence of bipolar I and II disorders in lateadolescence is about 1 per cent. Various studies in a large population have shown aprevalence rate of 0.1% -2%. The onset of bipolar disorder in children and adolescents is oftenaccompanied by a more severe disease course, compared to bipolar disorder with onset inadulthood. This case report presents a case of bipolar 1 in children accompanied bycomprehensive management.


2020 ◽  
Vol 10 ◽  
pp. 204512532097379
Author(s):  
Danielle Hett ◽  
Steven Marwaha

Bipolar disorder (BD) is a debilitating mood disorder marked by manic, hypomanic and/or mixed or depressive episodes. It affects approximately 1–2% of the population and is linked to high rates of suicide, functional impairment and poorer quality of life. Presently, treatment options for BD are limited. There is a strong evidence base for pharmacological (e.g., lithium) and psychological (e.g., psychoeducation) treatments; however, both of these pose challenges for treatment outcomes (e.g., non-response, side-effects, limited access). Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is a recommended treatment for unipolar depression, but it is unclear whether rTMS is an effective, safe and well tolerated treatment in people with BD. This article reviews the extant literature on the use of rTMS to treat BD across different mood states. We found 34 studies in total ( N = 611 patients), with most assessing bipolar depression ( n = 26), versus bipolar mania ( n = 5), mixed state bipolar ( n = 2) or those not in a current affective episode ( n = 1). Across all studies, there appears to be a detectable signal of efficacy for rTMS treatment, as most studies report that rTMS treatment reduced bipolar symptoms. Importantly, within the randomised controlled trial (RCT) study designs, most reported that rTMS was not superior to sham in the treatment of bipolar depression. However, these RCTs are based on small samples ( NBD ⩽ 52). Reported side effects of rTMS in BD include headache, dizziness and sleep problems. Ten studies ( N = 14 patients) reported cases of affective switching; however, no clear pattern of potential risk factors for affective switching emerged. Future adequately powered, sham-controlled trials are needed to establish the ideal rTMS treatment parameters to help better determine the efficacy of rTMS for the treatment of BD.


2019 ◽  
Vol 4 (4) ◽  
pp. 365-394
Author(s):  
Rong-Her Chiu

Purpose The first well-known liner shipping conference was created for the UK/Calcutta trade in 1875. However, the European Union (EU) decided to abolish repeal the liner conferences system with effect from October 18 2008. This paper aims to study the governing regulations on shipping conferences in Taiwan along with investigating the impact on the EU to repeal conferences. The regulation on liner conferences in the USA is also briefly referred. Design/methodology/approach Literature review and questionnaire survey are used to conduct the study. This paper reviews important literature relating to the EU to repeal the conferences system and its impact on liner market competition to/from European trade routes, with discussions on the US and Taiwan regulations on shipping conferences. Questionnaire survey data, collected from published report and this research present shippers’ and carriers’ responses on the changes of regulations on liner conferences. Findings Shippers are strongly supporting the repeal of the conferences system. Academic research results basically reveal that the liner market will be more competitive in the trades to/from the USA and the EU after the repeal of the conferences. For Taiwan, its regulations are rather simple and loosely control over the liner conferences; therefore, if the shipping administration intends to enhance the inspection of the agreements of conferences and strategic alliances, more detailed regulations should be prepared, and the provisions of the EU or USA would be a good reference. Practical implications Through the discussions on the legal treatments of shipping conferences from the USA, the EU and Taiwan perspectives, this paper provides shipping researchers with not only a clear evolution of the liner conferences but also a deep understanding of the impact to repeal the conferences on liner market competition. Originality/value This paper reviews important literature and related legislations on liner conferences including the USA, the EU and Taiwan. The different responses on the EU to repeal the conferences system from shippers and carriers are discussed. The impact on liner market competition is presented.


Author(s):  
Greta Carioli ◽  
Paola Bertuccio ◽  
Fabio Levi ◽  
Paolo Boffetta ◽  
Eva Negri ◽  
...  

Objective: To illustrate trends in sex ratios in epithelial cancer mortality in the EU, USA, and Japan, with a focus on age-specific and cohort patterns. Methods: We obtained certified deaths and resident populations from the World Health Organisation for the period of 1970–2014 for the USA, Japan, and the EU for 12 epithelial cancer sites. From these, we calculated both the age-specific and age-standardised male-to-female mortality sex ratios. We applied an age-period-cohort model to the sex ratios in order to disentangle the effects of age, period of death, and birth cohort. Results: Age-standardised mortality sex ratios were found to be unfavourable to males, apart from thyroid cancer. The highest standardised rates were in laryngeal cancer: 7·7 in the 1970s in the USA, 17·4 in the 1980s in the EU, and 16·8 in the 2000s in Japan. Cohort patterns likely to be due to excess smoking (1890 cohort) and drinking (1940 cohort) in men were identified in the USA, and were present but less defined in the EU and Japan for the oral cavity, oesophagus, liver, pancreas, larynx, lung, bladder, and kidney. Conclusion: Mortality sex ratio patterns are partly explained by the differences in exposure to known and avoidable risk factors. These are mostly tobacco, alcohol, and obesity/overweight, as well as other lifestyle-related factors.


2016 ◽  
Vol 8 (5) ◽  
pp. 39 ◽  
Author(s):  
Ye Mingque ◽  
Alena Slisava

<p>Nowadays non-tariff measures become more and more widely used. Russia is one of world largest importers of agri-products. In order to protect domestic production different non-tariff measures (NTMs) are used, which create difficulties for the exporters because NTMs are strict, changeable and difficult to deal with. This article analyses Russian non-tariff measures and their influence on the European Union exports of agri-products by using gravity model. The results show that Russian trade resistance is weaker for EU agricultural products exporters than for the USA exporters but stronger than for Chinese agricultural products exporters. The results do not prove that Russia’s NTMs have bigger impact on the EU exports than on the other countries’ exports such as India, Kyrgyz Republic, and the Ukraine. The NTM of such countries as China and Mexico also have much greater influence on the EU exports of agri-products than Russian NTMs.</p>


Author(s):  
Laura Bradford ◽  
Mateo Aboy ◽  
Kathleen Liddell

Abstract International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US–EU Privacy Shield††, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices.


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