Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment

Postgraduate Medicine
Timothy WigalManisha Madhoo

Abstract

Evaluate the efficacy, duration of effect, and safety of 25 mg SHP465 mixed amphetamine salts (MAS) extended-release versus placebo in adults with attention-deficit/hyperactivity disorder (ADHD). Adults (18-55 years) with ADHD and with ADHD Rating Scale-IV (ADHD-RS-IV) scores ≥24 were randomized to treatment in a double-blind, 2-period, 2-treatment crossover study utilizing the Adult Workplace Environment (AWE), as described by Wigal and Wigal (J Atten Disord 2006;10:92-111). On day 7 of each 7-day treatment period, efficacy was assessed during a 16.5-hour postdose period. The primary endpoint, Permanent Product Measure of Performance (PERMP) total score, was analyzed in the intent-to-treat population using a mixed linear model of analysis of variance. Secondary endpoints, for which the study was not powered, included PERMP problems attempted and answered correctly, ADHD clinician ratings based on counselor observations and inputs during the Time Segment Rating System (Co-ADHD-RS TSRS), and the ADHD self-rating scale (ADHD-SRS). Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs. The least squares mean (95% CI) treatment difference (SHP465 MAS-placebo) for PERMP total score si...Continue Reading

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References

May 20, 1998·Journal of the American Academy of Child and Adolescent Psychiatry·J M SwansonD P Cantwell
Sep 10, 2002·Journal of Psychosomatic Research·Jutta BackhausFritz Hohagen
Aug 19, 2003·Journal of the American Academy of Child and Adolescent Psychiatry·James T McCrackenSimon Tulloch
Jul 29, 2004·Journal of Consulting and Clinical Psychology·Betsy HozaTimothy Wigal
Jun 14, 2005·Journal of Occupational and Environmental Medicine·Ronald C KesslerT Bedirhan Ustün
Aug 20, 2005·Journal of Attention Disorders·Laura E KnouseKevin R Murphy
Jul 15, 2006·Journal of Attention Disorders·Sharon B Wigal, Timothy L Wigal
Dec 2, 2006·Biological Psychiatry·Thomas J SpencerUNKNOWN Adult ADHD Research Group
Apr 24, 2007·Journal of Attention Disorders·Lon CastleRobert S Epstein
May 25, 2010·Current Medical Research and Opinion·Matthew BramsFrank A López
Nov 25, 2011·European Psychiatry : the Journal of the Association of European Psychiatrists·I ManorG Zalsman
Feb 6, 2014·Attention Deficit and Hyperactivity Disorders·Mats FredriksenDawn E Peleikis
Oct 4, 2016·The American Journal of Psychiatry·James J McGough
Nov 10, 2016·The Primary Care Companion to CNS Disorders·Rakesh Jain, Alain Katic

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