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J. Clin. Med. 2019, 8(4), 461; https://doi.org/10.3390/jcm8040461

Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release

1
Child and Adolescent Psychiatry, Cambridge Health Alliance, Cambridge, MA 02138, USA
2
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV 89128, USA
3
Rhodes Pharmaceuticals L.P., Coventry, RI 02816, USA
4
Washington University School of Medicine, Washington University, St. Louis, MO 63110, USA
5
Midwest Research Group, St. Charles, MO 63304, USA
*
Author to whom correspondence should be addressed.
Received: 12 February 2019 / Revised: 25 March 2019 / Accepted: 29 March 2019 / Published: 5 April 2019
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Abstract

Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Remission has been defined as an endpoint score of less than or equal to 18 on the ADHD-RS-IV (or a mean score of 1). Responders have been defined as patients who achieve a CGI-I score of much or very much improved (1 or 2). There is a lack of agreement in the literature on what percent change in symptoms on the ADHD-RS-IV should be used to define improvement or remission. This study uses data from a clinical trial of a methylphenidate extended release (MPH-MLR; Aptensio XR®) phase III clinical trial to attempt to determine the percent change of symptoms that best corresponds with improvement and remission. Symptom remission at endpoint (ADHD-RS-IV total score ≤18) was most closely aligned with a ≥46% reduction in ADHD-RS-IV total score. Clinical improvement was most closely aligned with a ≥40% reduction in ADHD-RS-IV total score. The three different measures of outcome were strongly aligned during double blind and open label treatment, and were independent of subtype status. Our data suggest that at least 40% improvement in symptoms is needed to achieve a robust response at endpoint. View Full-Text
Keywords: attention deficit/hyperactivity disorder; central nervous system stimulants; methylphenidate; remission; response attention deficit/hyperactivity disorder; central nervous system stimulants; methylphenidate; remission; response
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Weiss, M.; Childress, A.; Nordbrock, E.; Adjei, A.L.; Kupper, R.J.; Mattingly, G. Characteristics of ADHD Symptom Response/Remission in a Clinical Trial of Methylphenidate Extended Release. J. Clin. Med. 2019, 8, 461.

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