Objectives: Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients. Methods:A multicenter, double-blind, active-controlled study was conducted using a daily dose of 8 mg endoxifen compared to 1000 mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with/without How to cite this article: Ahmad A, Sheikh S, Khan MA, et al.Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder. Bipolar
Clinical and epidemiological characteristics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now widely available, but there are few data regarding longitudinal serology in large cohorts, particularly those from low-income and middle-income countries. We established an ongoing prospective cohort of 3,840 SARS-CoV-2-positive individuals according to RT-PCR in the Delhi-National Capital Region of India to document clinical and immunological characteristics during illness and convalescence. The immunoglobulin G (IgG) responses to the receptor binding domain (RBD) and nucleocapsid were assessed at 0 to 7 days, 10 to 28 days, and 6 to 10 weeks after infection. The clinical predictors of seroconversion were identified by multivariable regression analysis. The seroconversion rates during the postinfection windows of 0 to 7 days, 10 to 28 days, and 6 to 10 weeks were 46%, 84.7%, and 85.3%, respectively ( N = 743). The proportion with a serological response increased with the severity of coronavirus disease 2019 (COVID-19). All participants with severe disease, 89.6% with mild to moderate infection, and 77.3% of asymptomatic participants had IgG antibodies to the RBD antigen. The threshold values for the nasopharyngeal viral RNA RT-PCR of a subset of asymptomatic and symptomatic seroconverters were comparable ( P = 0.48) to those of nonseroconverters ( P = 0.16) ( N = 169). This is the first report of longitudinal humoral immune responses to SARS-CoV-2 over a period of 10 weeks in South Asia. The low seropositivity of asymptomatic participants and differences between assays highlight the importance of contextualizing the understanding of population serosurveys.
Clinical and epidemiological characteristics of SARS-CoV-2 infection are now widely available, but there are little data on longitudinal serology in large cohorts, particularly from low-and middle-income countries. We established an ongoing prospective cohort of 3840 SARS-CoV-2 RT-PCR positive individuals in the Delhi-National Capital Region of India, to document clinical and immunological characteristics during illness and convalescence. The IgG responses to the receptor-binding domain (RBD) and nucleocapsid were assessed at 0-7, 10-28 days, and 6-10 weeks after infection. The clinical predictors of seroconversion were identified by multivariable regression analysis. The seroconversion rates in the post-infection windows of 0-7 days, 10-28 days, and 6-10 weeks were 46%, 84.7%, and 85.3% respectively (n=782). The proportion with a serological response increased with the severity of COVID-19 disease. All participants with severe disease, 89.6% with mild to moderate infection, and 77.3% of asymptomatic participants had IgG antibodies to the RBD antigen. The threshold values in the nasopharyngeal viral RNA RT-PCR in a subset of asymptomatic and symptomatic seroconverters were comparable (p-value: 0.48), with similar results among non-seroconverters (p-value: 0.16) (n=169). This is the first report of longitudinal humoral immune responses to SARS-CoV-2 infection over a period of ten weeks from South Asia. The low seropositivity in asymptomatic participants and differences between assays highlight the importance of contextualizing the understanding of population serosurveys.
The primary goal of the current study was to add to the literature regarding mental health implications of fire service membership. In the present study, 100 fire personnel were selected working in Haryana state of India. The DSM V cross cutting Questionnaire was used to assess mental health issues of the fire personnel and the results suggested that firefighters self-reported greater posttraumatic symptomatology on anger and substance issue domain of the test. In addition, the firefighters reported more distress on several subscales of the DSM V cross cutting Questionnaire
We reviewed Ghosh et al. 1 letter based on our active-controlled, double-blind, and randomized trial 2 that demonstrated the therapeutic benefit of Endoxifen in patients with bipolar I disorder. The author's reservations about the sample size estimation, statistical analysis, and missing data handling on the published article are unfounded. The clinical study design, conduct, and analysis were done under required regulatory and Good Clinical Practice guidelines. The non-inferiority margin was chosen based on consideration of our prior study. 3
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