Innovations In Clinical Neuroscience

Summit 2017

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

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Affiliations: 1 Bracket; 2 Johns Hopkins M edicine, Department of Psychiatry, 3 Children's National Medical Center, Department of Psychology and Behavioral Health Background/Objective: For the gold- s tandard pediatric depression scale, the Children's Depress Rating Scale (CDRS- R), we previously identified items of particular ratings to be challenging for US raters by detecting items of highest interrater variability. In the present study, we sought to identify such items, if present, in a non-US multi-trial international sample. Design: The analysis included 984 ratings of four standardized, paired patient/parent videos scored by investigators from 23 countries for multiply-sponsored trials. Per-country, per-item standard deviations (SDs) for each of the 17 CDRS-R scored items were computed for each video, eliminating the two country ratings that contained less than five raters. Item SDs were ranked by order representing least to most scoring variability. Ranks were assessed for cross-country and cross video agreement using Kendall W. Results: Within each video, cross- country agreement of SD rankings was statistically significant (P<0.0001). Collapsed across country, cross-video agreement of SD rankings was statistically significant (p<0.0002). Three high-SD items were among the top five for at least three of the four videos: Physical Complaints (PC), Low Self- Esteem (SE), and Hypoactivity (H). Conclusion: Items with high variance potentially harm signal detection. Two of the three high-SD items in this international sample (LSE and H) were also identified in the US analyses, suggesting the need for better standardization of conventions across countries. The new PC finding might reflect a need for nuanced cultural conventions for interpreting somatic illness expression. Overall, the findings can be used to inform training, remediation, and other scale guidance interventions in child and adolescent depression trials. Disclosures: J. Busner is a full-time employee of Bracket. In the past 12 months, R. L. Findling: In the past 12 months, Dr. Findling receives or has r eceived research support, acted as a consultant, and/or served on a speaker's bureau for Akili, Alcobra, Amerex, American Academy of Child & Adolescent Psychiatry, American P sychiatric Press, Bracket, Epharma Solutions, Forest, Genentech, Ironshore, KemPharm, Lundbeck, Medgenics, NIH, Neurim, Otsuka, PCORI, Pfizer, Physicians Postgraduate Press, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Syneurx, Takeda, Teva, TouchPoint, Tris, and Validus. A. Robb receives or has received research or travel support, acted as a consultant, served on a speaker's bureau, or owns stock or equity in American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, Bracket, Eli Lilly, Actavis/Allergan/Forest, GlaxoSmithKline, Johnson & Johnson Ser-vices, Lundbeck, NICHD, Otsuka, Pfizer, SyneuRX, Sunovion. She serves on the Advisory Board for Aevi Genomic Medicine, Neuronetics, NICHD EKS, NIMH, University of Cambridge; NCATS, NINDS, Pfizer, Inc., Supernus. She receives royalties from Guilford Press. TRIAL PROTOCOL A retrospective analysis of the effects of protocol design on completion rates in outpatient clinical trials in subjects with schizophrenia or schizoaffective disorder Presenters: Krefetz DG and Kazmi S Affiliations: PRA Health Sciences, Early Development Services, Marlton, NJ Background/Objective: We sought to identify protocol design variables that are associated with improved study completion rates in outpatient clinical trials in subjects with schizophrenia or schizoaffective disorder. Design: The authors previously conducted a retrospective analysis of the effects of protocol design on completion rates in Phase I inpatient studies with subjects with schizophrenia or schizoaffective disorder. The authors now study the impact of protocol design on study completion in outpatient clinical trials in subjects with schizophrenia or schizoaffective disorder. The authors examined the effect of 11 protocol design independent variables on c ompletion rates in 58 outpatient clinical trials with subjects with stable schizophrenia or schizoaffective disorder. These trials were conducted at three clinical trial sites from 2006 to 2016. The s ites enrolled 715 subjects in these trials. The variables studied include length of study, longest period between visits, number of visits, whether subject remained on pre-study antipsychotic, presence of a placebo arm, administration route of the investigational product, length of psychiatric stability required at screen, length of time since last trial participation required, whether the trial included subjects with schizoaffective disorder, phase of study, and the primary aim of the trial (safety, general efficacy, relapse prevention, negative symptom efficacy, or cognitive impairment efficacy). Variables were analyzed via a stepwise linear regression analysis to assess the predictive value of each variable with regard to study completion. Results: The predictive strength of each trial design variable on subject study completion is presented. Conclusion: Conclusions can be drawn that inform study design for better subject retention. Disclosures/funding: Nothing to disclose Toward more efficient methods for COA instrument selection in clinical trials Presenters: Zaragoza Domingo S 1 and Bishop K 2 Affiliations: 1 Neuropsychological Research Organization s.l., Barcelona, Catalonia, Spain, 2 Global Pharma Consultancy, USA Background/Objective: To innovate on clinical outcome assessments (COAs) and COA instrument selection by introducing the concept of efficacy-based selection. With this objective, a theoretical framework for existing initiatives is presented. Rationale: There is an urgent need in cognitive neuroscience to improve the efficiency of clinical trials. The selection of COAs for randomized, clinical trials (RCTs) has been increasingly gaining the attention of many public and private institutions (i.e., companies, scientific ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S17

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