Innovations In Clinical Neuroscience

CNS Summit 2016

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 4 , N U M B E R 1 – 2 , J A N U A R Y – F E B R U A R Y 2 0 1 7 , S U P P L E M E N T ] S8 This study examined patient completion time for the tablet-based eC-SSRS over time. D esign: Over 2,000 subjects with substance abuse disorder completed the tablet-based eC-SSRS assessment at each clinic visit in a trial. Data from the eC- SSRS since last contact version were a nalyzed. Results: Completion times for patients who scored negative for SIB using the tablet version of the e-C-SSRS were 1.15±1.33min at Visit 1, 0.84±0.89min at Visit 7, and 0.73±0.79min at Visit 12. There was a significant decrease in the time it took patients to complete the e- CSSRS across Visits 1 through 12 General Linear Model (mixed) (F=5809.25, p<0.0001). ANOVA repeated measures on all 12 visits (F=7.7, p<0.0001) showed that the time to complete the eC-SSRS decreased across visits. A t-test between Visit 1 and Visit 12 (p<0.0001, t=4.8) indicated that it took significantly less time for subjects to complete the eC-SSRS on Visit 12 versus Visit 1. Conclusion: These data showed that there was little burden on subjects to complete the tablet eC-SSRS, and this burden decreased with repeated administrations. This is a particularly important consideration in lengthy studies with many repeat collections of an SIB assessment. Disclosures/funding: Drs. Yamamoto, Durand, and Dallabrida and Ms. Lima and Mr. Christopher are employees of ERT Corp., New York, New York. Dr. Yershova is an employee of Columbia University/New York State Psychiatric Institute, New York, New York. The NetSCID: a validated web-based adaptive version of the SCID that improves diagnostic accuracy in mental health research Presenters: Brodey BB 1 , Zweede L 1 Affiliations: 1 TeleSage, Inc., Chapel Hill, North Carolina Background: The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID, DSM) is the gold standard for research-based mental health diagnoses. It is the most widely used comprehensive tool for assessing DSM diagnoses. Its direct adherence to DSM criteria provides strong test-retest and high interrater reliability; however, administration of the full research v ersion averages two hours and requires considerable clinician training, making it impractical for many protocols. Objective: Our objective was to develop and validate a highly configurable and s ecure web-based version of the SCID— the NetSCID— thereby making the gold standard in mental health diagnostics available for clinical trials. Methods: The validation research included 24 clinicians who administered the SCID to 230 participants that completed the paper SCID and/or the NetSCID. Data-entry errors, branching errors, and clinician satisfaction were quantified. Results: Ninety-seven percent of error rates occurred among clinicians administering the paper SCID; all errors that occurred when utilizing the NetSCID were subsequently corrected by our programmers. Administration time was reduced by over 30 percent. Clinicians found it easier to administer (p< 0.05), easier to navigate (p< 0.05), and simpler to score (p< 0.01). Ninety percent of clinicians preferred the NetSCID to its paper counterpart. Conclusion: Because of its unique ability to record symptoms in a standardized database, the NetSCID facilitates characterization of patient populations and assists with identification of sub-groups that may respond to interventions. Adoption of this tool has shown to improve diagnostic accuracy and will increase the power in central nervous system (CNS) clinical trials worldwide. Disclosures/funding: This research was supported in part by a grant from the National Institutes of Mental Health, which was awarded to TeleSage, Inc. Dr. Brodey is Chief Executive Officer of TeleSage, Inc., and Lisa Zweede is employed by TeleSage, Inc. as a clinical research specialist. DIGITAL MEDICINE Clinical trial of Clickotine ® , a Digital Therapeutics ™ solution for smoking cessation: design and total health execution methodology Presenters: Steinerman J 1 , Klein D 1 , Silver T 1 , Berger A 1 , Luo S 1 , Schork N 1 Affiliations: 1 Click Therapeutics, New York, New York Objective: The objective of this review w as to describe the efficient and effective execution of a clinical trial of a digital therapeutic for smoking cessation. Design: Clickotine is a mobile health solution for smoking cessation that c ombines evidence-based behavioral interventions with a unique engagement strategy that leverages personalization and contextualization. The potential utility of Clickotine was assessed in an open-label, eight-week study that focused on user- engagement, safety, tolerability, and smoking behavior efficacy. Key entry criteria included being 18 to 65 years of age, smoking five or more cigarettes per day, an interest in quitting smoking, ownership of an iPhone, living in the United States, and providing informed consent. The study employed remote telehealth interactions only. Designated sponsor representatives interacted directly with participants, while medical and scientific team members monitored and analyzed de-identified data. Participants were recruited via social media and a pre- screening telephone call. Informed consent and study questionnaires were delivered via an internet portal, complementing in- app data capture. Procedures for medical monitoring and biochemical verification of smoking cessation were in place throughout the study, which was institutional review board approved. Results: After 63 days of social media recruitment, 2,050 contacts were received and 617 telephone pre-screens were conducted, resulting in 452 participants providing online informed consent. Participants totaling 416 ultimately made up an intention-to-treat population broadly representative of United States smokers who want to quit. Baseline characteristics and details of telehealth trial execution were presented. Conclusion: Digital health enterprises can execute high-quality clinical trials by implementing social media recruitment, digital data capture, and remote interactions, while sparing resources and prioritizing participant convenience. Disclosures/funding: This study was funded by Click Therapeutics, New York, New York. JS is a consultant and shareholder of Click Therapeutics and an

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