Innovations In Clinical Neuroscience

2015 Abstracts of Poster Presentations

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

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 2 , N U M B E R 1 1 – 1 2 , N O V E M B E R – D E C E M B E R 2 0 1 5 , S U P P L E M E N T C ] 6 high toll on patients' lives and caregivers. More efficacious, safer treatments are needed. ITI-007 is in late-stage clinical development. O bjectives: Through synergistic actions via serotonergic, dopaminergic and glutamatergic systems, ITI-007 represents a novel approach to schizophrenia treatment. Methods: ITI-007-005 is a four- week Phase II trial; 335 patients were randomized to receive one of four treatments orally once daily: ITI- 007 (60mg or 120mg), risperidone (positive control), or placebo. ITI- 007-301 is the first of two Phase III trials, wherein 450 patients were randomized to receive either ITI-007 (60mg or 40mg) or placebo for four weeks. In the second Phase III trial ITI- 007-302 (ongoing), approximately 580 patients are planned to be randomized to receive ITI-007 (60mg or 20mg), risperidone (positive control), or placebo. The primary efficacy endpoint is the Positive and Negative Syndrome Scale (PANSS) total score change from baseline versus placebo. Results: ITI-007 60mg significantly improved schizophrenia symptoms on the primary endpoint (least squares [LS] mean change -13.2 points vs -7.4 points; P=0.017, MMRM, ES=0.4) in Phase II. Risperidone (4mg) differed from placebo on the PANSS total demonstrating assay sensitivity. ITI- 007 was safe and well-tolerated. Secondary analyses indicated improved negative symptoms and symptoms of depression. An update from the Phase III program will be presented. Conclusion: ITI-007 represents a novel direction for the treatment of schizophrenia with unique pharmacologic properties and a differentiating clinical profile. The benefits of ITI-007 in schizophrenia continue to be elucidated in this late- stage clinical program.[ Disclosures: ITI-007 is an investigational drug in development funded by Intra-Cellular Therapies, Inc. (ITI). KEV, CO'G, JS, MW, and SM are employees of ITI. RED is a paid consultant to ITI. DEVICES High-resolution actigraphy and advanced signal processing objectively quantifies nocturnal scratching events in patients with atopic dermatitis Presenters: 1 Peterson B, 2 Almazan T, 2 Craft N 1 Moreau A, 1 Anderer P, 1 Cerny A, 1 Ross M Affiliations: 1 Philips Healthcare; 2 Science 37 Background: Atopic dermatitis is an inflammatory skin condition that is associated with pruritus. A method for objectively quantifying nocturnal scratching events could aid in the development of therapies for pruritic disorders. Objective: To assess the accuracy of an objective, non-invasive method to quantify nocturnal scratching events in patients with atopic dermatitis using high-resolution actigraphy. Methods: Nine adults with atopic dermatitis and three healthy adults were enrolled in the study. High- resolution actigraphy devices were placed on both wrists and worn during one night in a sleep lab that included video recording. Time and duration of scratching events were scored by a trained medical observer watching the video. The subjects also completed scratching questionnaires in the morning. The actigraphy devices captured three-dimensional acceleration data at 100Hz. A combined neural networks and features analysis algorithm was developed to distinguish scratching episodes from other movements. Results: Total nighttime scratching events detected by the wrist-worn actigraphy device data correlated well with scratching events determined by scoring the videos (r=0.96 p<0.001). Among the subjective assessments, the visual analog scale provided the best correlation with the video scoring but it was not very strong (r=0.77, p<0.01). Conclusion: In this initial study, nocturnal scratching determined by high-resolution actigraphy and advanced signal processing c orrelated well with scratching episodes identified visually. Additional data are needed to confirm the validity of this approach. The ease of actigraphy use in a home setting makes it a potentially useful tool in clinical trials to evaluate new therapies for atopic dermatitis. Probabilistic sleep models as improved EEG-based biomarkers for subjective sleep quality Presenters: 1 , 2 Dorffner G, 1 , 3 Aydemir Ö Affiliations: 1 Medical University of Vienna, Austria; 2 The Siesta Group; 3 Karadeniz Technical University Background: Electroencephalography (EEG), as part of polysomnography (PSG), together with other electrophysiological measurements, is the gold standard biomarker for measuring sleep. Correlations of PSG variables to subjective sleep quality assessments are very poor. Objective: In this study we explored novel probabilistic sleep models based on EEG data to prove that such correlations can be increased by extracting more information about sleep microstructure. Methods: We applied a previously developed probabilistic sleep model (PSM) to data from 270 subjects and calculated proper descriptive variables (e.g., area under the curve, entropy, spectral content) from the resulting probabilistic curves describing the main sleep processes. We then calculated linear regression models on optimized subsets of such variables regressing on a standard subjective sleep assessment score. For comparison, we performed the same procedure with variables from traditional PSG-based sleep variables (e.g., sleep efficiency, percentage in each sleep stage). Results: Results show that Pearson correlation coefficients between sets of probabilistic sleep

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