Christopher J Kratochvil1, David Michelson2, Jeffrey H Newcorn2, Margaret D Weiss2, Joan Busner2, Rodney J Moore2, Dustin D Ruff2, Janet Ramsey2, Ruth Dickson2, Atilla Turgay2, Keith E Saylor2, Stephen Luber2, Brigette Vaughan2, Albert J Allen2. 1. Dr. Kratochvil and Ms. Vaughan are with The University of Nebraska Medical Center, Omaha; Dr. Newcorn is with Mount Sinai Medical Center, New York; Dr. Weiss is with The Children's and Women's Health Centre of British Colombia, University of British Colombia, Vancouver; Dr. Busner is with the Pennsylvania State College of Medicine, Hershey, and PharmaStar, Wayne, PA; Dr. Turgay is with the University of Toronto, Scarborough, Ontario; Dr. Saylor is with NeuroScience, Inc., Herndon, VA; Dr. Luber is with the Rockwood Clinic, Spokane, WA, and the University of Washington Medical School, Seattle; Ms. Ramsey and Drs. Michelson, Moore, Ruff, and Allen are with the Eli Lilly Research Laboratories, Indianapolis; Dr. Dickson is with Eli Lilly Canada, Toronto.. Electronic address: ckratoch@unmc.edu. 2. Dr. Kratochvil and Ms. Vaughan are with The University of Nebraska Medical Center, Omaha; Dr. Newcorn is with Mount Sinai Medical Center, New York; Dr. Weiss is with The Children's and Women's Health Centre of British Colombia, University of British Colombia, Vancouver; Dr. Busner is with the Pennsylvania State College of Medicine, Hershey, and PharmaStar, Wayne, PA; Dr. Turgay is with the University of Toronto, Scarborough, Ontario; Dr. Saylor is with NeuroScience, Inc., Herndon, VA; Dr. Luber is with the Rockwood Clinic, Spokane, WA, and the University of Washington Medical School, Seattle; Ms. Ramsey and Drs. Michelson, Moore, Ruff, and Allen are with the Eli Lilly Research Laboratories, Indianapolis; Dr. Dickson is with Eli Lilly Canada, Toronto.
Abstract
OBJECTIVE: To assess the utility and tolerability of higher than standard atomoxetine doses to treat attention-deficit/hyperactivity disorder (ADHD). METHOD: Two randomized, double-blind trials of atomoxetinenonresponders ages 6 to 16 years were conducted comparing continued treatment with same-dose atomoxetine to treatment using greater than standard efficacious doses (study 1: up to 3.0 mg . kg . day; study 2: up to 2.4 mg . kg . day). RESULTS: The primary outcome measure for both studies was mean ADHD Rating Scale (ADHD RS) total score. For study 1 (N = 122), decreases in ADHD RS total scores were not significantly different between treatment groups (mean change [SD]: continued same dose, -8.9 [11.2]; high dose, -9.8 [13.1]; p = .595). Likewise, for study 2 (N = 125), treatment groups did not differ (mean change [SD]: continued same dose, -6.2 [12.2]; high dose, -8.9 [10.0], p =.110). Tolerability was not significantly different between the continued same-dose and high-dose groups. CONCLUSIONS: These studies provide evidence that current dose recommendations are appropriate for most patients, suggesting no systematic advantage to increasing atomoxetine doses beyond current guidelines. In both studies, continued treatment, whether at a higher dose or the previous dose, was associated with improved outcomes in patients who demonstrated incomplete/inadequate response to acute ADHD treatment, although without a placebo arm, we cannot rule out the possibility that expectancy played a role in symptom improvement.
RCT Entities:
OBJECTIVE: To assess the utility and tolerability of higher than standard atomoxetine doses to treat attention-deficit/hyperactivity disorder (ADHD). METHOD: Two randomized, double-blind trials of atomoxetine nonresponders ages 6 to 16 years were conducted comparing continued treatment with same-dose atomoxetine to treatment using greater than standard efficacious doses (study 1: up to 3.0 mg . kg . day; study 2: up to 2.4 mg . kg . day). RESULTS: The primary outcome measure for both studies was mean ADHD Rating Scale (ADHD RS) total score. For study 1 (N = 122), decreases in ADHD RS total scores were not significantly different between treatment groups (mean change [SD]: continued same dose, -8.9 [11.2]; high dose, -9.8 [13.1]; p = .595). Likewise, for study 2 (N = 125), treatment groups did not differ (mean change [SD]: continued same dose, -6.2 [12.2]; high dose, -8.9 [10.0], p =.110). Tolerability was not significantly different between the continued same-dose and high-dose groups. CONCLUSIONS: These studies provide evidence that current dose recommendations are appropriate for most patients, suggesting no systematic advantage to increasing atomoxetine doses beyond current guidelines. In both studies, continued treatment, whether at a higher dose or the previous dose, was associated with improved outcomes in patients who demonstrated incomplete/inadequate response to acute ADHD treatment, although without a placebo arm, we cannot rule out the possibility that expectancy played a role in symptom improvement.
Authors: Nicola C Savill; Jan K Buitelaar; Ernie Anand; Kathleen Ann Day; Tamás Treuer; Himanshu P Upadhyaya; David Coghill Journal: CNS Drugs Date: 2015-02 Impact factor: 5.749
Authors: Mark E Bangs; Ling Jin; Shuyu Zhang; Durisala Desaiah; Albert J Allen; Holly A Read; Arie Regev; Joachim F Wernicke Journal: Drug Saf Date: 2008 Impact factor: 5.606
Authors: Jean C Dinh; Robin E Pearce; Leon Van Haandel; Andrea Gaedigk; J Steven Leeder Journal: Drug Metab Dispos Date: 2016-04-06 Impact factor: 3.922
Authors: Azmi Nasser; Tesfaye Liranso; Toyin Adewole; Nicholas Fry; Joseph T Hull; Fatima Chowdhry; Gregory D Busse; Zare Melyan; Andrew J Cutler; Robert L Findling; Stefan Schwabe Journal: Psychopharmacol Bull Date: 2021-03-16