Presented at the CHADD 2018 Annual International Conference on ADHD, November 8-11, 2018 in St. Louis, Missouri
A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL REGISTRATION TRIAL (STARS-ADHD) TO ASSESS THE EFFICACY AND SAFETY OF A NOVEL, HOME-BASED, DIGITAL TREATMENT FOR PEDIATRIC ADHD
S.H. Kollins,1 J. Bower,2 T. Ala’ilima,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 E. Cañadas,2 S.V. Faraone8 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; 4VeraSci, 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
Introduction:
• 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.
• 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.