Presented at AACAP Annual Meeting, Seattle, WA, USA, October 22-27, 2018
A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL REGISTRATION TRIAL(STARS-ADHD) TO ASSESS THE EFFICACY AND SAFETY OF A NOVEL, HOME-BASED, DIGITAL TREATMENT FOR PEDIATRIC ATTENTION-DEFICIT HYPERACTIVITY DISORDER
S.H. Kollins,1 J. Bower,2 R.L. Findling,3 R. Keefe,1,4 J.N. Epstein,5 A.J. Cutler,6 R. White,7 L. Aberle,7 D. DeLoss,2 S.V. Faraone8 31249 1Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; 2Akili Interactive, Boston, MA, USA; 3Child and Adolescent Psychiatry, Johns Hopkins University/Kennedy Krieger Institute, Baltimore, MD, USA;4NeuroCog Trials, Inc., Durham, NC, USA; 5Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital, Cincinnati, OH, USA; 6Psychiatry, Meridien Research, Tampa, FL, USA; 7Duke Clinical Research Institute, Durham, NC, USA; 8Psychiatry and Neuroscience & Physiology, SUNY Upstate Medical University, New York, NY, USA
• There are well-established pharmacologic and non-pharmacologic treatments for attention-deficit hyperactivity disorder (ADHD),1-4 but limitations to these treatments likely contribute to poor adherence over time. There is an ongoing need for novel approaches to ADHD treatment.
• AKL-T01 is an investigational therapeutic digital intervention in development for the treatment of attention and inhibitory control deficits in pediatric ADHD. – A proof-of-concept study of AKL-T01 demonstrated feasibility of use, improved attention, response inhibition, and working memory in pediatric patients with ADHD.5
• We present primary efficacy and safety results of the randomized Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) trial of AKL-T01 versus an active control in pediatric patients with ADHD.