Treatment of Depression with Vortioxetine and Second Generation Antipsychotics During the Period of Remission Formation in Schizophrenia (Interim Data Analysis)

BACKGROUND: Depression in patients with schizophrenia worsens the course of the disease by increasing the risk of suicide, by complicating the clinical picture of the disorder, and by reducing the quality of the social functioning; its treatment is difficult, since monotherapy, even when involving modern antipsychotics, does not always prove successful. While the prescription of additional antidepressants (ADs) can improve the likelihood of a better outcome, the effectiveness of such augmentation in many cases is yet to be proven. Therefore, it is still important that one weighs the effectiveness of various combinations between most of the known ADs and some second-generation antipsychotic (SGA) in the treatment of depression that occurs at different stages of schizophrenia. In previous studies, the use of vortioxetine as an adjunct to an antipsychotic yielded a reduction in negative symptoms, a clinically significant improvement in cognitive functions that differed from its antidepressant effect, and good tolerability, which affects how committed to treatment a patient remains. AIM: To study the changes that occur over time in the clinical manifestations of depression, negative and cognitive impairment, as well as the social adequacy of patients receiving a combination therapy with second-generation antipsychotics and vortioxetine, which were prescribed in real clinical practice at doses approved in the Russian Federation. METHODS: We performed a comparative analysis of the changes in depression symptoms and negative symptoms, cognitive impairment, as well as function of 78 patients with severe manifestations of depression at the stage of exacerbation reduction and subsequent remission of paranoid schizophrenia. Combination treatment with SGA and vortioxetine was used in 39 patients, and 39 patients who had similar clinical manifestations received just SGA. During the observation period, the mental disorder severity and depression symptom severity were assessed 3 times (before the start of treatment, after three months, and after six months) using the Clinical Global Impression (CGI) scale and Calgary Depression Scale for Schizophrenia (CDSS), respectively; patients were also assessed using the Negative Symptoms Assessment-5 (NSA-5) scale, Perceived Deficits Questionnaire-20 items (PDQ-20) scale, and Personal and Social Performance (PSP) scale. RESULTS: According to the ANOVA results, by the end of the observation period, patients, regardless of their therapeutic group, showed a statistically significant decrease in the level of depression on the CDSS scale, the severity of negative symptoms on the NSA-5 scale, cognitive symptoms on the PDQ-20 scale, as well as an improvement in personality and society, judging by the increase in the total PSP scores. There were also significant differences between the compared main (SGA + vortioxetine) and control (SGA) groups in terms of the changes in the total score on the CDSS and PSP scales. An interesting aspect of the changes in the clinical scores was a noticeable improvement in the SGA + vortioxetine group after 3 months of treatment, in the absence of a similar improvement in the control group, and the achievement of approximately the same scores in both groups after 6 months. In particular, there were significant differences between the SGA + vortioxetine and SGA groups in terms of the mean CDSS (p 0.001), NSA-5 (p=0.003), PDQ-20 (p 0.001), and PSP (p=0.004) scores after 3 months. Analysis of the time before early withdrawal from the study showed that significantly more patients in the SGA + vortioxetine group completed the study program (n=27, 69.23%) compared with the SGA group (n=13, 33.33%) (2 =14.618, df=1, p 0.001, log-rank test. The mean survival time in the SGA group was significantly (p 0.001) less and amounted to 101.436 days (95% CI: 81.518121.354), and in the SGA + vortioxetine group it amounted to 161.744 days (147.981175.506). The relative risk of full study completion in the vortioxetine + SGA group compared with that in SGA was 3.618 (1.8716.994). CONCLUSION: The addition of vortioxetine to the SGA therapy accelerates the reduction of the depression symptoms that occur at the stage of psychosis regression and early remission, contributes to the accelerated reduction in negative symptoms, positively affects the subjective assessment of cognitive impairment severity, and has a significant positive effect on the level of psychosocial functioning

Immunogenicity evaluation of Gam-COVID-Vac (Sputnik V)

In November 2020, the Armed Forces of the Russian Federation began mass immunisation of the personnel with Gam-COVID-Vac (Sputnik V), the first Russia vaccine against the new coronavirus infection (COVID-19). Thus, it became necessary to assess post-vaccination antibody levels and the duration and intensity of humoral immunity to COVID-19.The aim of the study was to investigate the immunogenicity and efficacy of Gam-COVID-Vac in military medical staff after vaccination.Materials and methods: the authors determined the presence of specific antibodies in the serum of individuals immunised with Gam-COVID-Vac (477 volunteers) and COVID-19 convalescents (73 patients), using virus neutralisation (VN), enzyme-linked immunosorbent assay (ELISA) with reagent kits by several manufacturers, and immunoblotting. The results of the study were evaluated using analysis of variance.Results: VN detected virus neutralising antibodies in 90.7% of vaccinated subjects; ELISA, in 95.4%. Both VN and ELISA showed lower antibody levels in the vaccinated over 50 years of age. ELISA demonstrated a significantly higher concentration of anti-SARS-CoV-2 spike IgG in the Gam-COVID-Vac group than in the COVID-19 convalescent group. The correlation between antibody detection results by VN and ELISA was the strongest when the authors used their experimental reagent kit for quantitative detection of virus neutralising antibodies by competitive ELISA with the recombinant human ACE2 receptor. Having analysed the time course of neutralising antibody titres, the authors noted a significant, more than two-fold decrease in geometric means of the titres three months after administration of the second vaccine component.Conclusions: the subjects vaccinated with Gam-COVID-Vac gain effective humoral immunity to COVID-19. The decrease in titres indicates the need for revaccination in 6 months

Изучение иммуногенности вакцины Гам-КОВИД-Вак

In November 2020, the Armed Forces of the Russian Federation began mass immunisation of the personnel with Gam-COVID-Vac (Sputnik V), the first Russia vaccine against the new coronavirus infection (COVID-19). Thus, it became necessary to assess post-vaccination antibody levels and the duration and intensity of humoral immunity to COVID-19.The aim of the study was to investigate the immunogenicity and efficacy of Gam-COVID-Vac in military medical staff after vaccination.Materials and methods: the authors determined the presence of specific antibodies in the serum of individuals immunised with Gam-COVID-Vac (477 volunteers) and COVID-19 convalescents (73 patients), using virus neutralisation (VN), enzyme-linked immunosorbent assay (ELISA) with reagent kits by several manufacturers, and immunoblotting. The results of the study were evaluated using analysis of variance.Results: VN detected virus neutralising antibodies in 90.7% of vaccinated subjects; ELISA, in 95.4%. Both VN and ELISA showed lower antibody levels in the vaccinated over 50 years of age. ELISA demonstrated a significantly higher concentration of anti-SARS-CoV-2 spike IgG in the Gam-COVID-Vac group than in the COVID-19 convalescent group. The correlation between antibody detection results by VN and ELISA was the strongest when the authors used their experimental reagent kit for quantitative detection of virus neutralising antibodies by competitive ELISA with the recombinant human ACE2 receptor. Having analysed the time course of neutralising antibody titres, the authors noted a significant, more than two-fold decrease in geometric means of the titres three months after administration of the second vaccine component.Conclusions: the subjects vaccinated with Gam-COVID-Vac gain effective humoral immunity to COVID-19. The decrease in titres indicates the need for revaccination in 6 months.В начале массовой иммунизации личного состава Вооруженных Сил Российской Федерации в ноябре 2020 г. первой в России вакциной Гам-КОВИД-Вак против новой коронавирусной инфекции COVID-19 необходимо было оценить уровень антител у вакцинированных лиц, длительность и напряженность гуморального иммунитета против COVID-19.Цель работы: изучение иммуногенной эффективности вакцины Гам-КОВИД-Вак у сотрудников военных лечебных учреждений после вакцинации.Материалы и методы: наличие специфических антител в сыворотке крови лиц, иммунизированных вакциной Гам-КОВИД-Вак (477 добровольцев), и переболевших COVID-19 (73 пациента) определяли в реакции нейтрализации, методами иммуноферментного анализа (ИФА) с использованием наборов реагентов различных производителей и иммуноблоттинга. Статистическую обработку результатов исследования проводили методами вариационной статистики.Результаты: установлено, что у 90,7% вакцинированных выявляются вируснейтрализующие антитела в реакции нейтрализации, и у 95,4% – в ИФА. Отмечено снижение уровня антител, выявляемых в реакции нейтрализации и ИФА, у вакцинированных старше 50 лет. Концентрация иммуноглобулина класса G к S-белку вируса SARS-CoV-2, определяемая в ИФА у группы лиц, иммунизированных вакциной Гам-КОВИД-Вак, достоверно выше, чем в группе переболевших COVID-19. Наибольший уровень корреляции результатов определения антител в ИФА и реакции нейтрализации получен при использовании экспериментального набора реагентов для количественного выявления вируснейтрализующих антител методом конкурентного ИФА с использованием рекомбинантного человеческого ангиотензинпревращающего фермента АСЕ2. Изучение динамики изменений уровня вируснейтрализующих антител показало, что через три месяца после введения второго компонента вакцины отмечается достоверное снижение уровня антител более чем в два раза.Выводы: у лиц, иммунизированных вакциной Гам-КОВИД-Вак, формируется эффективный гуморальный иммунитет к возбудителю COVID-19. Снижение среднего геометрического значения титров антител в два раза через три месяца после введения второго компонента вакцины Гам-КОВИД-Вак свидетельствует о необходимости проведения ревакцинации через 6 месяцев после введения второго компонента вакцины

Basic Formal Education Quality, Information Technology and Inclusive Human Development in Sub-Saharan Africa

This study assesses the relevance of basic formal education in information technology for inclusive human development in 49 countries in sub-Saharan Africa for the period 2000-2012. The question it aims to answer is the following: what is the relevance of basic formal education in the effect of mobile phone penetration on inclusive human development in sub-Saharan Africa when initial levels of inclusive human development are taken into account? The empirical evidence is based on instrumental quantile regressions. Poor primary education dampens the positive effect of mobile phone penetration on inclusive human development. This main finding should be understood in the perspective that, the education quality indicator represents a policy syndrome because of the way it is computed, notably: the ratio of pupils to teachers. Hence, an increasing ratio indicates decreasing quality of education. It follows that decreasing quality of education dampens the positive effect of mobile phone on inclusive development. This tendency is consistent throughout the conditional distribution of inclusive human development. Policy implications for sustainable development are discussed