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 ] 4 CPT1 positively or negatively affected by the structural modifications to carnitine. Disclosures: There are no c onflicts of interest related to the content of this poster. A randomized, double-blind, placebo-controlled, four-period, cross-over study assessing the next-day residual effects of flibanserin on simulated driving performance in healthy premenopausal female volunteers Presenters: 1 Kay G, 2 Natarajan KK, 1 Horohonich S, 1 Hochadel T Affiliations: 1 Cognitive Research Corporation; 2 Sprout Pharmaceuticals, Inc. Background: This study compared the next-day residual effects of acute and steady-state nighttime doses of flibanserin (100mg/day and 200mg/day) on simulated driving performance and cognition in healthy female subjects. Objective: To test for negative effects on measures of next-day simulated driving performance and cognitive testing Methods: Healthy, premenopausal females (18–-50 years of age) were randomized to flibanserin (100mg or 200mg), zopiclone (7.5mg), or matching placebos the evening prior to testing in a double-blind, placebo-controlled, Latin-square design, with four-way, four-period crossover (n=83). Zopiclone was selected as a positive control for assay sensitivity. On the first day of each treatment period, subjects were dosed with flibanserin, zopiclone, or matching placebo at bedtime. Prior to dosing, they completed a practice drive on the CRCDS-MiniSim and a practice trial on the CogScreen digit-symbol substitution test (SDC). Subjects were awakened approximately seven hours later and within 60 minutes of awakening performed the SDC Test and self-report measures. Subjects then performed the Country Vigilance-Divided Attention (CVDA) driving scenario (100km) approximately nine hours post- dosing. Results: Compared to placebo, standard deviation of lateral position ( SDLP) values were significantly increased following dosing with zopiclone (+3.1cm on Day 2; and +3.5cm on Day 8; both p<0.0001). In contrast, relative to placebo, SDLP values decreased following acute (-2.5cm; p=0.0009) and steady-state (-1.8cm; p=0.0126) dosing with flibanserin (100mg/day). Flibanserin also did not have a deleterious effect on other driving parameters or on cognitive performance. Conclusions: Therapeutic and supra-therapeutic doses of flibanserin had no negative effect on measures of next-day simulated driving performance and cognitive testing. Effect of as-needed use of intranasal PH94B on social and performance anxiety in individuals with social anxiety disorder Presenters: Liebowitz M, Hanover R, Draine A, Lemming R, Careri J, Monti L Affiliations: The Medical Research Network, LLC Background: There are no medications approved for use on an as-needed basis for feared social or performance situations for individuals with social anxiety disorder. Objective: In the present study, PH94B, a novel synthetic neurosteroidal molecule that is administered intranasally in microgram doses, was used as needed during everyday stressful social events. Methods: Twenty-two subjects were randomized (double-blind) to two weeks of treatment with intranasal PH94B or placebo. Following self-administration of medication prior to an anticipated fearful event, peak levels of anxiety were recorded using the Subjective Units of Distress Scale (SUDS). Subjects were crossed over to the opposite treatment for two weeks. Average peak SUDS during treatment with PH94B and placebo was compared. Results: Significant differences in f avor of PH94B were found on the primary outcome measure. The mean SUDS peak score for all subjects receiving PH94B was 51.1 versus 58.4 for placebo (paired t: 3.09, p=0.006, effect size of 0.658). PH94B showed greater superiority over placebo when placebo was given first than second, likely due to a carryover effect. Looking at just the first two weeks of treatment, PH94B also showed trend superiority to placebo on the Liebowitz Social Anxiety Scale (p=0.07) and a significant difference on the Patient Global Impression of Change (p=0.024) Conclusion: While further study is needed, these results, combined with earlier findings, suggest that PH94B could represent a useful PRN treatment for social anxiety disorder, and continue to validate the nasal chemosensory system as a novel mechanism for medication delivery. Disclosures: The study was conducted at the Medical Research Network, a clinical trial facility in New York City owned by Dr. Liebbowtz, and was funded by Pherin Pharmaceuticals, the manufacturer of PH94B. Drs. Liebowitz, Hanover, and Monti have stock options and/or stock in Pherin, and Dr. Monti is the executive VP of Pherin. A novel clinical trial design to evaluate the safety and efficacy of TAK-375SL in the maintenance treatment of bipolar I disorder: preliminary results Presenters: Mahableshwarkar AR, Hanson E, Budur K, Macek T, Ogrinc F, Dong X, Hloros E, Tokimoto P, Sachs G Affiliations: Takeda Pharmaceuticals Background: A randomized withdrawal design is often used to demonstrate the benefit of long-term treatment to prevent relapse in patients with Bipolar I disorder

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