Innovations In Clinical Neuroscience

Summit 2017

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

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MOBILE TECHNOLOGY High frequency assessment of mood and cognition in major depressive disorder using the Apple iWatch Presenters: Cormack F 1,2 , McCue M 3 , S chuster J 3 , Taptiklis N 1 ,2 , Glazer E 1 ,4 , Panagopoulos E 1,4 , Van Sheik T 1,4 , Fehnert B 1,4 , King J 1,4 , and Barnett JH 1,2,5 Affiliations: 1 Cognition Kit, Cambridge UK; 2 Cambridge Cognition, Cambridge UK; 3 Takeda Pharmaceuticals USA, Deerfield IL; 4 CTRL Group, London UK; 5 University of Cambridge Department of Psychiatry, Cambridge UK Background/Objective: Patients with major depressive disorder (MDD) frequently experience cognitive problems, such as inattention and memory complaints. These are often under-recognized and might affect patients' ability to accurately self-report symptoms. High frequency, near-patient testing might aid communication between patients and clinicians by overcoming challenges, such as recall bias. This study aimed to assess the feasibility, accuracy, and acceptability of daily assessments of cognition and mood implemented on an Apple iWatch in participants with MDD. Design: Thirty participants between 18 and 65 years of age with mild-to- moderate single or recurrent major depressive episode prescribed antidepressant monotherapy were enrolled. Brief cognitive and mood tests were administered daily through the Cognition Kit application on Apple iWatch in a single-arm, unblinded, six- week observational study. Performance was measured on Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive function tests and patient-reported measures of depression symptom severity, social function, and perceived cognitive difficulties on four occasions. At the first and final visit, a semi-structured interview was carried out to assess subjective motivation and barriers to adherence. Results: Participants showed excellent adherence with daily testing of both mood (95%) and cognition (96%). Abbreviated daily assessments delivered through this wearable device showed good correspondence with full-length p atient reported outcomes and objective CANTAB cognitive tests. Conclusion: Near-patient testing using wearable devices is feasible and well-tolerated by patients with d epression. Good correspondence with patient reported outcomes and objective measure was shown, providing a novel, patient-centric methodology for frequent assessment of a range of symptoms. Disclosures/funding: Project funded by Takeda Pharmaceuticals USA. Patient engagement text messaging reduces drug interruption and patient dropout in Phase III bipolar depression clinical trial Presenters: Curtin D, Johnson M, Putnam T, and Griffin A Affiliations: mProve Health, LLC, QuintilesIMS Background/Objective: We aimed to define the impact of patient engagement text messages for patients participating in a bipolar depression clinical trial, and to evaluate patients' protocol adherence and dropout rate. Design: In an ongoing Phase III, double-blind, safety and efficacy study for patients with bipolar depression, study-related text messages were offered to patients. These messages included daily medication reminders, study visit reminders, and appreciation messages to alert patients of protocol obligations. Participating research sites were given the option of offering these communications to patients, thereby creating comparators of patients, one receiving communications and second comparator that did not. The impact of receiving study communications was assessed across the two patient comparators using two measures: drug interruption and study discontinuation. Results: The average number of drug interruption protocol deviations for patients receiving communications versus patients not receiving communications were 0.03 and 0.26, respectively, for an 85-percent reduced risk in drug interruption (p=0.05). Trial sites who offered study communications to patients had 250-percent fewer patient withdrawals than sites who did not offer communications. Conclusion: Employing text message r eminders to support patients in completing protocol obligations, such as dosing and scheduled visits, consistently demonstrate positive effects on protocol deviations and retention. S upportive communications encourage adherence to time-sensitive medication dosing in addition to enabling patient engagement through study completion, thereby limiting the need for further recruitment and enrollment costs. Project STARR911 Presenters: Hendry P, Armstrong K, Barag J, and Kramer L Background/Objective: The STARR Coalition is a nonprofit organization consisting of thought leaders throughout the pharmaceutical industry, CROs, clinical research sites, and advocacy. Our mission is to build unbiased, collaborative initiatives to reduce the stigma associated with CNS disorders and promote research as an option for those seeking help. A strong link exists between mental illness and suicide. Are opportunities available for clinical research in psychiatric disorders to make a difference? Up to 20 percent of individuals with a diagnosis of mental illness complete suicide. Ninety percent of those who complete suicide experience mental illness. People considering suicide usually seek help: 64 percent who attempt suicide visit a doctor a month before their attempt. Having a chronic condition increases the odds of suicide by 363 percent. This poster reviews the need to integrate suicide prevention education and support into clinical research's processes and culture. What currently happens when a person with suicidal thoughts calls a research site? Design: "STARR911" is a concept to build collaboration between clinical research and suicide prevention. Clinical research call centers field thousands of calls on a yearly basis. During first contact, operators are trained on best practices to recognize callers who might have suicidal ideation. Options might include educational information, de- escalation techniques, and access to "warm" handoffs to suicide prevention specialists. The concept can be adopted ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S10

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