Innovations In Clinical Neuroscience

Summit 2017

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

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women ages 19 to 59 years with g eneralized social anxiety disorder underwent single-blind doses of placebo intranasal spray 15 minutes before laboratory simulated performance and social challenges ( Visit 2). Those showing a predefined level of significant distress returned a week later (Visit 3) to receive, on a double-blind, randomly assigned basis, either intranasal PH94B (1.6µg) or placebo aerosol spray 15 minutes before repeat performance and social challenges. Results: Patients receiving PH94B at Visit 3 had a significantly greater decrease in the mean Subjective Units of Distress Scores (SUDS) during the public speaking challenge and a trend toward lower SUDS scores during the social interaction challenge at Visit 3, as compared to Visit 2, than patients who had received placebo at both visits. PH94B also significantly exceeded placebo in percentage of patients much or very much improved (72% vs. 23%) when comparing the Visit 3 to the Visit 2 challenges. Conclusion: These preliminary results suggest that PH94B might be an effective acute treatment for performance and social anxiety. Disclosures/funding: Sponsored by Pherin Pharmaceuticals. Lamotrigine for ketamine dependence: a randomized, double-blind, placebo- controlled trial Presenters: Lin SK 1 , Huang MC 1 , and Chen CK 2 Affiliations: 1 Taipei City Hospital, Taipei, 2 Chang Gung Memorial Hospital, Keelung, Taiwan Background/Objective: Ketamine has become a popularly abused substance worldwide, including Taiwan in recent years, especially among the young and adolescent population. Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder, with its main pharmacological mechanism being sodium channel blocking. It also inhibits the release of glutamate through modulation of high voltage-activated calcium currents and sodium channels. The aim of this clinical trial was to investigate the efficacy of lamotrigine in the treatment o f ketamine dependence. Design: After randomization, the dosage of study medication (25mg/day) was administered to subjects for seven days in a double-blind, placebo- c ontrolled design. The dose was increased gradually to 100mg to 200mg/day by the end of 12 weeks. The primary end was negative result of urine screen between lamotrigine and placebo, and secondary ends were retention rate, subjective visual analogue scales (VAG) of craving, and clinical global impression of severity (CGI-S). Results: In total, 17 subjects (lamotrigine: 9, placebo: 8) were enrolled in this trial. There was no difference in terms of demographics, history of substance use, and clinical severity. After treatment, no difference was found between the two groups, while a significant improvement was noticed within subjects in assessments of VAG and CGI-S. Conclusion: Due to the small sample size, this trial did not find a better efficacy of lamotrigine in the treatment of ketamine use disorder, while a significant placebo effect was noticed. Disclosures/funding: This study was registered in ClinicalTrial.gov (NCT02556060) and sponsored by Taipei City Government (10401-62-042). We thank Lotus pharmaceutical, Taiwan for sponsoring the trial drug and placebo. PH94B nasal spray a PRN treatment for social anxiety disorder: a Phase 3 pilot trial Presenters: Liebowitz MR 1 , Monti L 2 , Hanover R 3 , and Draine A 1 Affiliations: 1 Medical Research Network, New York, NY, 2 Pherin Pharmaceuticals, Los Altos, CA, 3 Westport Compass, Salt Lake City, UT Background/Objective: Social anxiety disorder is a prevalent anxiety disorder that is often chronic and disabling. An effective rapidly acting pro re nata (PRN) treatment for social anxiety disorder could be highly useful. Design: The study reported here was a Phase 3 pilot trial of PH94B, a synthetic neurosteroid delivered intranasally that acts via nasal chemosensory receptors to rapidly a ffect brain structures involved in anxiety. Subjects with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of social anxiety disorder carried a diary for two w eeks, recording anxiety-producing social or performance events. Those who met predetermined criteria were randomized to two weeks of PH94B (1.6- and 3.2µg) or placebo, used PRN up to four times/day, followed by two weeks on the opposite treatment. Results: Twenty-two subjects were included in efficacy assessments. PH94B was significantly more effective than placebo on the primary outcome measure, self-rated subjective units of distress (SUDS) scores of peak anxiety in feared situations, and, using between- subjects comparisons of the first two weeks of data, on several important secondary measures. Adverse effects were mild and did not show drug placebo differences. Conclusion: If larger follow-up Phase III trials confirm our findings, PH94B could represent the first systematically studied PRN treatment for social anxiety disorder that could be used either as monotherapy or potentially as an adjunctive treatment. Disclosures/funding: Sponsored by Pherin Pharmaceuticals. A retrospective case-matched study of the efficacy of the MedicaSafe BupeCare device Presenters: Mattai A Affiliations: MedicaSafe, Inc. Objectives: We sought to determine whether introducing a tracking and daily dispensing technology for medication- assisted maintenance treatment to patients with opioid use disorder would correlate with reduced illicit opioid use in the population. Design: The dispenser was introduced to a portion of patients attending a clinic in White Plains, New York, who were diagnosed with opioid use disorder and stably maintained on buprenorphine treatment at least one point during their course of treatment. Paper records, including baseline assessment data, were maintained and reviewed for all patients. Urine and oral ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S8

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