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STUDY OBJECTIVES The INSYTE study provides an understanding of the management of Parkinson disease psychosis (PDP) in actual practice settings, including use of antipsychotic (APs) and their impact on clinical, economic, and humanistic outcomes. Treatment paradigms or the benefits/consequences of various “real world” PDP treatment strategies have not been evaluated. Thus, providers may be using a wide range of AP treatment strategies that contrast with consensus recommendations. METHOD The INSYTE study is enrolling up to 750 patients from up to 100 sites in the US. Data are compiled at the baseline (BL) visit and from standard-of-care follow up visits over 3 years. PDP treatment pathways are defined from 3 BL cohorts reflecting (1) no AP medication, (2) use of pimavanserin (PIM), or (3) other AP treatment. Information about APs used is collected at each follow-up visit history, duration, dose, adjustment, and rationale for adjustment of treatment. Outcomes assessments (clinical, quality of life, disease burdethways. The numerous distinct AP treatment pathways utilized (n=26) reflect discordance with the updated 2019 MDS evidence-based recommendations, which recognize only 2 APs as “efficacious” and “clinically useful” pimavanserin and clozapine. Education of healthcare professionals remains a priority for PDP management. FUNDING ACKNOWLEDGEMENTS ACADIA Pharmaceuticals Inc.STUDY OBJECTIVE(S) This study examined the effects of lemborexant (LEM) compared with placebo (PBO) on subject-reported insomnia disease severity, assessed by the Insomnia Severity Index (ISI), and fatigue, assessed by the Fatigue Severity Score (FSS), from the 6-month PBO-controlled period of SUNRISE-2. METHOD SUNRISE-2 (NCT02952820; E2006-G000-303) was a 12-month randomized, double-blind, PBO-controlled (first 6-months) Phase 3 study. After an ~2-week PBO run-in, subjects were randomized to PBO, LEM 5mg (LEM5) or LEM 10mg (LEM10) for 6 months. The ISI and the FSS were administered at baseline [BL] and at the end of Months 1, 3, and 6. The ISI daytime functioning score (DFS), based on the ISI items that assess the impact of insomnia symptoms specific to daily functioning (items 4-7), was also evaluated. Mean changes from BL in ISI total score (ISI TS), ISI DFS, and FSS total score (FSS TS) were analyzed using a mixed-effect model repeated measurement analysis, adjusted for relevant factors and BL score (ISI vely. Mean FSS TS decreased (improved) from BL in all groups at the end of Month 1 (decreases were larger and significant for LEM10 vs PBO [LSM TD -2.0 (P=0.026)]), and Month 3 (decreases were larger and significant for LEM5 [LSM TD -2.2 (P=0.021)] and LEM10 [LSM TD -3.0; (P=0.001)] vs PBO). At Month 6, mean FSS TS remained improved from BL in all treatment groups (PBO, -6.3; LEM5, -10.1; and LEM10, -8.9). These decreases were larger and significant for LEM5 (LSM TD -2.5 [P=0.013]) and LEM10 (LSM TD -2.6 [P=0.013]) vs PBO. LEM was well tolerated with most adverse events mild to moderate in severity. CONCLUSIONS In SUNRISE-2, LEM5 and LEM10 significantly reduced subject-reported disease severity and fatigue vs PBO after 6 months of treatment. Reduced severity in insomnia symptoms with LEM5 and LEM10 also translated to improved daytime functioning. FUNDING ACKNOWLEDGEMENTS Supported by Eisai Inc.The term Catatonia was coined by Kraepelin in 1893 and was categorized as a subtype of dementia praecox. Bleuler in 1906 redefined it as catatonic Schizophrenia. Over the period of time by accumulating evidence of various case reports and studies its apparent that catatonia is not only seen in Schizophrenia, Affective disorders but is also seen secondary to various medical problems. There is very limited literature describing catatonia in the presence of neurological problems like Encephalopathy. The pathophysiology of Catatonia remains unclear. Given the involvement of common substrates like GABA, Dopamine and glutamate that are altered in many neurological problems and catatonia the differentiation and treatment become complicated. METHOD We present the case of a 32-year-old male with bipolar II disorder, who was initially went through elective cholecystectomy complicated by bowel perforation and septic shock. Patient had to be intubated and had complicated ICU stay. Various consultation services including of 3 weeks with a very slow but good response. CONCLUSION This case reflects the intricacy in diagnosing Catatonia complicated by Encephalopathy and the challenges in its treatment. We want to add on to the current literature on Catatonia masked by multiple medical comorbidities and the challenges of treatment.INTRODUCTION Major depressive disorder (MDD) has been ranked among the top causes worldwide of years lived with disability. In this study we assessed meaningful change for the PHQ-9 and the SDS and determined the meaningful change threshold (MCT) using anchor-based methods, which could be used to compare meaningful differences in patients within different treatment arms. METHODS TRANSFORM-1 (NCT02417064) and -2 (NCT0241858) were Phase 3 trials that evaluated the efficacy and safety of fixed and flexible doses of esketamine nasal spray (56 mg or 84 mg) in combination with newly initiated oral antidepressant (ESK+AD) vs oral antidepressant + placebo nasal spray (AD+PBO) in TRD patients. Patient Reported Outcomes (PROs) were integrated into these trials to evaluate the patient perspective of treatment using instruments capturing concepts of importance to patients. The 9-item Patient Health Questionnaire (PHQ-9) is a PRO instrument used to assess self-reported depression symptoms and the Sheehan Disability Scale sed MCTs ranging from 5 to 8 points. The magnitude of change (standardized effect size estimate within-subject change) for patients improving was exceptionally high (> 0.80). Similar results were observed on the SDS high correlation of CGI-S and SDS at Day 28 (0.75), moderate SES (0.66), with suggested MCT ranging from 3 to 7 with an MCT value of 5 pts. CDF curves from TRANSFORM-2 showed clear separation between the ESK+AD vs AD+PBO across a number of responder definitions inclusive of those identified with the anchor-based analyses. read more CONCLUSIONS The current study is the first to derive an MCT on the PHQ-9 and SDS in TRD to measure meaningful change from the perspective of the patient using regulatory-preferred psychometric anchor-based methodology. These analyses assist with interpretation of meaningfulness of esketamine phase 3 clinical trial results from the patient perspective. FUNDING ACKNOWLEDGEMENTS Study was funded by Janssen Global Services, LLC.