Innovations In Clinical Neuroscience

Summit 2017

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

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quality checks identifying discrepancies a ssociated with negative items of the PANSS. In the current analysis, we explore this battery in a database of 17 schizophrenia clinical trials. Design: Data from 17 Phase II and III d ouble-blind, placebo-controlled, multicenter schizophrenia trials were analyzed. Each visit was tested for the presence of errors associated with the negative items. Using logistic and negative binomial regression we assessed the association between the presence of these errors in the screening and post-baseline periods. Results: The dataset consisted of 73,115 visits administered across 11,487 subjects. Errors associated with negative symptoms were identified in nearly 15 percent of visits in acute schizophrenia studies and in more than 22 percent of visits in studies with predominantly negative symptoms. The presence of the errors in the screening period was associated with 8.4-times increased odds and with a 328-percent increased incidence of recording the same errors after baseline. Conclusion: We have developed a battery of data quality checks focusing on errors associated with PANSS negative items. The presence of these errors in the screening period was highly associated with their reoccurrence after baseline. Intelligent eCOA and data-analytic approaches should be used to screen for these errors and trigger subsequent remedial intervention, preferably before subject's randomization. Disclosures/funding: Both authors are full-time employees of Bracket. Effect of predominance of negative symptoms at baseline on change in the PANSS total in acute schizophrenia trials—an exploratory analysis Presenters: Kott A, Daniel DG Affiliations: Bracket Global, LLC Background/Objective: We aimed to evaluate the effect of predominance of negative symptoms over positive symptoms on change from baseline to last visit in acute schizophrenia trials. Design: Blinded data were analyzed for 6,700 subjects in 10 double-blind, placebo-controlled studies of acutely ill subjects with schizophrenia. Based on b aseline scores on the Positive and Negative Syndrome Scale (PANSS) negative subscale score and the PANSS positive subscale, the sample was dichotomized into two groups: subjects w ith more severe positive symptoms than negative symptoms and subjects with more severe negative than positive symptoms. At the end of treatment, we compared the change in the PANSS total score between the two groups within each protocol using a two-sided t-test. Results: Among the 10 studies, at baseline the severity of negative symptoms exceeded the severity in positive symptoms in 32 to 46 percent of subjects, mean=38.2 percent (SE=0.8). Differences among the studies in the proportion of predominantly negative symptom and predominantly positive symptom subjects at baseline were statistically significant (c 2 (9)=27.4, p<0.01). We identified no differences between the magnitude of the PANSS total change from baseline to end of treatment by negative or positive symptom predominance in nine out of the 10 analyzed studies. In one study, the mean change in the group with more severe negative symptoms was significantly different (indicating greater improvement) from the group with more severe positive symptoms (- 21.8±19.1 vs. -17.7±18.8; t(424)=2.18, p<0.05). Conclusion: Our data suggest that more severe negative than positive symptoms at baseline usually do not reduce change at end of treatment compared to subjects with more severe positive than negative symptoms. The current exploratory data analysis is blinded to treatment status and thus does not address the effects of the ratio of negative to positive symptoms at baseline on placebo-drug differences. This question will be addressed in future analyses. Real-world patient experience with treatment-emergent sexual dysfunction in depression Presenters: Jacobsen J 1 , Thorley EM 2 , Curran C 2 , and Chiauzzi E 2 Affiliations: 1 Takeda Development C enter Americas Inc., 2 P atientsLikeMe, Inc. Objectives: Despite the prevalence of treatment-emergent sexual dysfunction (TESD) in antidepressant treatment, l ittle is known about patients' related real-world experiences. Design: A cross-sectional survey (N=483) was developed and fielded to members from PatientsLikeMe, an online data-driven patient network self reporting major depressive disorder (MDD). Sexual functioning was assessed using the Changes in Sexual Functioning Questionnaire-short form (CSFQ-14) and a patient attribution question. Survey measures also included the Patient Health Questionnaire Depression Scale (PHQ- 8), and the Couples Satisfaction Index-4 (CSI-4). Results: Based on CSFQ scores, 56 percent of the participants taking antidepressants reported sexual dysfunction. Sexual dysfunction was associated with depression severity for both women and men and was associated with lower relationship satisfaction (CSI-4) among women currently taking antidepressants. Based on patient attribution, less than half with TESD mentioned it to their doctor, and a minority (ranging 20–36%) indicated that their doctor subsequently switched them to another antidepressant. In response to issues with sexual functioning, 48 percent stated they continued taking their current antidepressant(s) until sexual side effects went away; 36 percent adjusted their dosing (lower dose, skipped dose); and 11 percent indicated taking another medication to improve sexual functioning. Conclusion: Sexual dysfunction is associated with greater depression severity and relationship dissatisfaction. Despite various actions taken by patients to ameliorate sexual dysfunction, over half currently taking antidepressants were still experiencing TESD. Disclosures/funding: Paula Jacobsen is an employee of Takeda Development Center Americas Inc. This study was funded by Takeda Pharmaceuticals U.S.A., Inc. ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S12

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