Innovations In Clinical Neuroscience

Summit 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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programs. Examples include b ioequivalence in East Africa, surveillance and control of tuberculosis (TB) in Central Asia, developing a vaccine for arboviruses in Latin America, monitoring malaria resistance, and i dentifying local communities where HIV is most prevalent. Successful implementation of our programs requires reflective practice supported by a mentorship program. Intervention or response: The global expansion of internet access presents opportunities to close gaps in professional knowledge and skills through technology enhanced training. Such training can be customized to the specific needs of a program, varying from approaches that blend online with classroom teaching, to complete online courses that are mentor-led. They can also vary from certificate to higher degrees. The Faculty of Capacity Development was formed by faculty from Karolinska Institutet, Sweden, to deliver this type of competency and confidence enhancing training. We want to enable health professionals to deliver the "right interventions to the right population at the right time." Our mission is to support clinical research, improve professional practice, and save lives. The Foundation for Child Development (FCD) currently runs a program with the Global Health Clinical Consortium, which consists of the World Health Organization Special Programme for Research and Training in Tropical Diseases (WHO TDR), Aeras, Drugs for Neglected Diseases Initiative, Foundation for Innovative New Diagnostics, Global Alliance for TB Drug Development, International AIDS Vaccine Initiative, Infections Disease Research Institute, International Partnership for Microbicides, International Vaccine Institute, Medicines for Malaria Venture, and PATH. This program uses a combination of blended learning and mentoring to achieve higher levels of professional practice and organizational capacity development in a number of low and middle-income countries (LMICs). Results: Technology-enhanced education upholds the principles of equity in that the quality of content can be guaranteed regardless of where the candidates are located. It drastically reduces costs and allows the learner to p ace learning to his or her schedule as much as possible. Conclusion: Members of FCD have successfully delivered programs that improve clinical research capabilities in d eveloped economies, as well as LMICs. Partners have included Pfizer, Novartis, AstraZeneca, the Drug Information Association (DIA), and the European Union's Innovative Medicines Initiative. Adapting our structured mentoring program to the needs of clinical researchers in the United States could potentially close many of the gaps in skills and capacity currently developing between the re-search required to introduce new medicines in CNS and the capacity of the industry to successfully carry out that research. INVESTIGATIVE DRUG COMPOUNDS AND THERAPIES Efficacy of vortioxetine in working patients with generalized anxiety disorder Presenters: Christensen MC 1 , Loft H 1 , Florea I 1 , and McIntyre RS 2 Affiliations: 1 H. Lundbeck A/S, Copenhagen, Denmark; 2 University Health Network, University of Toronto, Canada Background/Objective: Vortioxetine is an approved antidepressant that has also demonstrated positive effects on anxiety symptoms in subjects with generalized anxiety disorder (GAD). This post-hoc analysis evaluates the effect of vortioxetine in GAD subjects working/pursuing education. Design: In NCT00744627, 301 GAD subjects were randomized to vortioxetine 5mg or placebo for eight weeks. Efficacy measures included Hamilton Anxiety Rating Scale (HAM-A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form (36) Health Survey [SF-36]). In NCT00788034, 687 GAD subjects were treated open-label with vortioxetine 5- or 10mg for 20 weeks after which subjects in remission were randomized to fixed dose of 5- or 10mg or placebo for at least 24 weeks. Primary endpoint was time to relapse. Analyses were completed in subjects working/pursuing education at study e ntry and the full analysis set. Results: In NCT00744627, the effect versus placebo on HAM-A total score was -4.3 (p=0.0005) in working subjects (60% of total), and the effect in the total p opulation was -3.8 (p=0.0001). The effect was greatest in professional (-4.5; p=0.0130) and associate professional positions (-7.6; p=0.0086). Greater effects on response, remission, SDS, and SF-36 were also observed. In NCT00788034, working subjects (69%) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio 2.9; p<0.001). The hazard ratio in total population was 2.7 (p< 0.0001). Conclusion: The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD working/pursuing education versus full GAD study population. Disclosures: Data for this study were from clinical studies sponsored by H. Lundbeck A/S, Valby, Denmark and Takeda Pharmaceuticals Inc., Deerfield, Illinois. I. M.C. Christensen, DrPH, H. Loft, PhD, and I. Florea, MD are employees of H. Lundbeck A/S. R. McIntyre has received research grants and attended speakers bureaus from the following private industries: Bristol- Myers Squibb, Janssen-Ortho, Eli Lilly, Lundbeck, Pfizer, Takeda, Otsuka, and Purdue. An intranasal aerosol for social anxiety disorder Presenters: Liebowitz MR 1 , Salmán E 1 , Rosenthal N 2 , Nicolini H 3 , and Monti L 4 Affiliations: 1 Medical Research Network, N.Y., N.Y.; 2 Capital Clinical Research, Rockville, MD; 3 Carracci Medical Group, Mexico City, Mexico; 4 Pherin Pharmaceuticals, Los Altos, CA. Background/Objective: Although social anxiety disorder is a common and sometimes disabling condition, there are no approved pro re nata (PRN) treatments. Design: A Phase II, multicenter, randomized, double-blind, placebo- controlled, single-dose study of a nanogram dose intranasal aerosol was conducted at three sites. Ninety-one ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S7

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